Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Mometasone furoate 0.1%w/w Ointment

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Mometasone furoate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Mometasone furoate
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Mometasone furoate contains the active substance mometasone furoate, which belongs to a group of medicines called topical corticosteroids (or steroids). Topical corticosteroids can be divided into four degrees of strength or potency: mild, moderate, potent and very potent. Mometasone furoate is classified as a "potent corticosteroid". In adults and children, aged 2 years and over, Mometasone furoate is used to reduce symptoms caused by certain inflammatory skin disorders such as psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis. This ointment preparation is generally used to treat very dry, scaly and cracked skin complaints. It is not a cure for your condition, but should help to relieve your symptoms. 2.

What you need to know before you take it

e Mometasone furoate

Do not use Mometasone furoate: • • •

• •

If you are allergic to mometasone, other corticosteroids or any of the other ingredients of this medicine (listed in section 6). If the skin lesion is infected without simultaneously treating the infection On any other skin problems as it could make them worse especially rosacea (a skin condition affecting the face), acne, skin atrophy (thinning of skin), dermatitis around the mouth, perianal and genital itching, nappy rash, bacterial infections such as impetigo, tuberculosis (infection of the skin), syphilis (a sexually transmitted disease), viral infections such as cold sores, shingles, chickenpox, warts, parasitical infections such as scabies, fungal infections such as athlete's foot (red, itchy, flaky skin on the feet) or thrush, an infection affecting the vagina that can cause discharge and itching or other skin infections. On open skin wounds or where the skin is ulcerated. If you have recently had a reaction to a vaccination (e.g. for flu).

Warnings and precautions

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Talk to your doctor or pharmacist before or during treatment if any of the following affect you before or whilst using Mometasone furoate. Corticosteroids can mask, activate or worsen a skin infection. If irritation or sensitisation develops with the use of Mometasone, you should tell your doctor immediately. When this medicine is used on psoriasis, it may make the condition worse (e.g. a pustular form of the disease may occur). You should let your doctor review your progress at regular intervals; as such treatment needs careful supervision. Whilst using Mometasone furoate if an infection develops in the skin you are treating then you should talk to your doctor as soon as possible. If the infection does not respond to the anti-infective treatment you may need to stop applying Mometasone furoate until the infection is controlled. Application of Mometasone furoate to a large area of the body or under occlusion (for example for children under a nappy, under or in the skin folds or under dressings) can increase the risk of the steroid being absorbed through the skin. If absorbed, mometasone furoate can cause some side effects in the body. If you need to apply to a large area, under dressings or a nappy or in the skin folds ask your doctor or pharmacist for advice before applying.

Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children. The ointment should not be put on the eyelids. Take care not to get any ointment in the eye as, very rarely, cataracts (clouding of the eye lens) or glaucoma (raised pressure in the eye) can occur. Normally you should also not apply to the face. If your doctor recommends applying to the face, normally this should be for no more than 5 days. Contact your doctor if you experience blurred vision or other visual disturbances. During treatment with Mometasone furoate in the genital or anal area, the excipient white soft paraffin and simultaneous use of latex condoms can lead to a reduction in tensile strength, increasing the risk of condom failure. Mometasone furoate may be used for children over 2 years of age, however special care should be used (see details below). Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Other medicines and Mometasone furoate Tell your doctor or pharmacist if you are taking or using, have recently taken or used or might take or use any other medicines, including medicines obtained without a prescription and any other remedies or dietary supplements such as vitamins. Ask your doctor for advice before taking any medicine. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If your doctor does prescribe the ointment to you during pregnancy or while you are breast-feeding, you should avoid using large doses and use only for a short period. It is not known if the medicine may be present in breast milk after you have applied to the skin. To prevent accidental indigestion, Mometasone furoate should not be applied to the breast area whilst breast-feeding. Page 2 of 6

Ask your doctor for advice before taking or using any medicine. Mometasone furoate contains propylene glycol and butylhydroxytoluene Mometasone furoate contains propylene glycol, which may cause skin irritation, and butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. 3.

How to take it

Mometasone furoate Type of administration Mometasone furoate is for cutaneous use (use on the skin). This medicinal product is for external use only. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Use in Children Mometasone furoate is not recommended for children under the age of 2. Your doctor should review your treatment at regular intervals. Adults, including older people and children 2 years of age and older The recommended dose is a thin layer of ointment gently applied to the affected areas of skin once daily. Normally, one fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand. Never apply more than this quantity or more often than advised by your doctor or pharmacist. Special care should be used • • • •

If recommended to be applied to the face, do not use the ointment for more than 5 days without close supervision of your doctor. You should not use the ointment on large areas of the body (over 20% of body surface area) or for a long time (for example every day for over 3 weeks). Avoid getting the ointment in your eyes. Unless directed by your doctor, do not apply a bandage or dressing to the area being treated. This will increase absorption of the preparation and increase possible side effects.

Use in children and adolescents:

  • Do not use the ointment for children over 2 years of age, on any part of their body, without close supervision of the doctor. Do not apply the ointment to more than a maximum of 10% of the child's body surface area for no more than 5 days. Do not apply the ointment under a child's nappy, as this may make it easier for the medicine to pass through the skin (see also Warnings and precautions). If you use more Mometasone furoate than you should If you accidentally swallow the ointment, it should not normally produce any undesirable effects. However, if you are worried, you should see your doctor or pharmacist. If you use the ointment more often than you should, or on large areas of the body, it can affect some of your hormones. In children, this may affect their growth and development.

Page 3 of 6

If you have not followed the dosage instructions or your doctor's advice and have used the ointment too frequently and/or for a long time, you should tell your doctor or pharmacist. If you forget to use Mometasone furoate If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then carry on as before. Do not apply twice as much or use twice in one day to make up for a missed application. If you stop using Mometasone furoate Do not stop treatment suddenly if you have used it for a long time since this may be harmful. Treatment should be stopped gradually, as advised by your doctor as you may develop a severe rash that is very red, itchy and painful. To stop using Mometasone, gradually use less with each application or use Mometasone less frequently (e.g. every other day). If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If your symptoms do not begin to improve after using this preparation as instructed by your doctor or if they get worse, check with your doctor. If you notice any of the following side effects, stop taking this medicine and contact your doctor or go to the nearest hospital casualty department straight away: •

Cushing's syndrome which may include many symptoms such as rapid weight gain, especially of the trunk and face, and general weakness, particularly in children treated with corticosteroids as they can absorb more of this medicine through the skin.

Other side effects in children and adults that have been reported with the use of topical corticosteroids include: Common (may affect up to 1 in 10 people): •

Tingling or stinging sensation

Uncommon (may affect up to 1 in 100 people): • •

Formation of small nodules and pimples After prolonged and intensive treatment thinning of the skin (skin atrophy) may occur which can lead to increased uptake and increased risk of side effects, ruptures in superficial blood vessels, skin infections, irregular skin marks or stripes (including stretch marks) and rosacea like redness of the facial skin.

Rare (may affect up to 1 in 1000 people): • • •

Treatment of large body areas, can have an impact on the adrenal glands. This effect disappears when treatment is discontinued. Excessive hair growth (hypertrichosis) Allergic reactions in the form of increased redness, itching, tingling and skin irritation

Page 4 of 6

Very rare (may affect up to 1 in 10,000 people): • • •

Inflammation of the skin follicles Burning sensations Itching

Not known (cannot be estimated from the available data): • • • •

•

An infection of the skin, or pus-filled blisters/boil. You should talk to your doctor as soon as possible (see also Warning and precautions) Tingling or numbness in your arms and legs (paraesthesia) Application site pain or irritation Visible small blood vessels under the skin, thinning of the skin, skin inflammation (including acne type reactions), a red itchy scaly rash which may be around the mouth, changes in skin colour, purple or dark blue discoloration of the skin, sensitisation, stinging, dryness, maceration of the skin (softening and whitening), prickly heat (a very itchy rash) Blurred vision

Increased usage, treatment of large areas of skin, long term use and use under a dressing may increase the risk of side effects. Corticosteroids may affect the normal production of steroids in the body. This is more likely to happen if high doses are being used over a long period of time. Additional side effects in children and adolescents Children on long-term treatment may grow more slowly than others. Your doctor will help prevent this happening by prescribing the lowest dose of steroid at which your symptoms are well controlled. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects no listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

Mometasone furoate

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Discard the opened tube with any remaining ointment after 12 weeks. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.

Contents of the pack and further information

What Mometasone furoate contains The active substance is mometasone furoate. Each gram of Mometasone furoate contains 1 mg of the active substance mometasone furoate. Page 5 of 6

The other ingredients are hexylene glycol; phosphoric acid, concentrated (for pH adjustment); propylene glycol monopalmitostearate; beeswax, white; paraffin, white soft; butylhydroxytoluene (E321) (as an antioxidant) and water, purified. What Mometasone furoate looks like and contents of the pack Mometasone furoate is a clear white soft, smooth ointment. The ointment is filled in aluminium tubes fitted with a white polyethylene piercing screw cap in a cardboard carton. Pack sizes: Tubes with 10 g, 15 g, 20 g, 30 g, 50 g, 60 g or 100 g of ointment. Not all packs sizes may be marketed. Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL United Kingdom Viatris UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary This leaflet was last revised in 11/2023

Page 6 of 6

Frequently asked questions about Mometasone furoate 0.1%w/w Ointment

How do I take Mometasone furoate 0.1%w/w Ointment?

Mometasone furoate 0.1%w/w Ointment comes as ointment containing 0.1%. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Mometasone furoate 0.1%w/w Ointment?

The active substance in Mometasone furoate 0.1%w/w Ointment is mometasone furoate.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Mometasone furoate 0.1%w/w Ointment, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Mometasone furoate 0.1%w/w Ointment without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Mometasone furoate (16 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Mometasone furoate 0.1% w/w Ointment is indicated for the symptomatic treatment of inflammatory and pruritic skin conditions which respond to external treatment with glucocorticoids, such as atopic dermatitis and psoriasis (excluding widespread plaque psoriasis).

Mometasone furoate 0.1% w/w Ointment should be preferably used to treat very dry, scaly and cracked skin complaints where a topical mometasone preparation is indicated.

4.2. Posology and method of administration

Posology

Adults, including older people and children aged 2 years and over: A thin film of Mometasone furoate 0.1% w/w Ointment should be applied to the affected skin area once daily until improvement is seen.

The frequency of application should then be decreased gradually.

Strong topical corticosteroids generally should not be applied to children or to the face without close monitoring by the physician. The amount applied should be limited to the least amount compatible with an effective therapeutic regimen and duration of the treatment should be no longer than 5 days (see section 4.4).

Mometasone furoate 0.1% w/w Ointment should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children a maximum of 10% of body surface area should be treated.

Use of a weaker corticosteroid is often advisable when there is a clinical improvement.

Paediatric population

Children below 2 years:

Mometasone furoate is a potent group III glucocorticoid. It is not recommended for use in children below 2 years due to insufficient data on safety.

Method of Administration

Cutaneous use.

4.3. Contraindications

Hypersensitivity to the active substance, other corticosteroids, or to any of the excipients listed in section 6.1.

Mometasone furoate is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster, chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections of the skin if causal therapy is not administered concomitantly, varicella, tuberculosis, syphilis or post-vaccine reactions.

Mometasone furoate should not be used on wounds or on skin which is ulcerated.

4.4. Special warnings and precautions for use

If irritation or sensitisation develop with the use of Mometasone furoate 0.1% w/w Ointment, treatment should be withdrawn and appropriate therapy instituted.

Glucocorticoids can mask, activate or worsen a skin infection.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

Visual disturbances

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Paediatric population

Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of mometasone furoate in paediatric patients below 2 years of age have not been established, Mometasone furoate 0.1% w/w Ointment is not recommended in this age group. Mometasone furoate may be used with caution in paediatric patients 2 years of age or older, although the safety and efficacy of the use of mometasone furoate for longer than 3 weeks have not been established.

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on face, courses should be limited to 5 days. Long term continuous therapy should be avoided in all patients irrespective of age.

Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment.

Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.

Mometasone furoate 0.1% w/w Ointment is not for ophthalmic use, including the eyelids because of the very rare risk of glaucoma simplex or subcapsular cataract.

Mometasone furoate 0.1% w/w Ointment contains propylene glycol which may cause skin irritation and also butylhydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membrane.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.

Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5. Interaction with other medicinal products and other forms of interaction

During treatment with mometasone ointment in the genital or anal area, the excipient of white soft paraffin and the simultaneous use of latex condoms can lead to a reduction in tensile strength, reducing the safety of the condoms.

4.6. Fertility, pregnancy and lactation

Pregnancy

During pregnancy treatment with Mometasone furoate 0.1% w/w Ointment should be performed only on the physician's order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation (see section 5.3). There are no adequate and well-controlled studies with mometasone furoate in pregnant women and therefore the risk of such effects to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human foetus. Like other topically applied glucocorticoids, Mometasone furoate 0.1% w/w Ointment should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.

Breast-feeding

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Mometasone furoate should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. During breast-feeding mometasone ointment should not be used on the breast area. If treatment with higher doses or long term application is indicated, breast-feeding should be discontinued.

4.7. Effects on ability to drive and use machines

Mometasone furoate 0.1% w/w Ointment has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Table 1: Treatment-related adverse reactions reported with mometasone furoate by body system and frequency

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data)

Infections and infestations

Very rare

Folliculitis

Not known

Infection, furuncle

Endocrine disorders

Rare

Adrenal cortex inhibition

Nervous system disorders

Very rare

Burning sensation

Not known

Paraesthesia

Eye disorders

Not known

Blurred vision (see section 4.4)

Skin and subcutaneous tissue disorders

Common

Tingling, stinging sensation

Uncommon

Papular rosacea-like dermatitis (facial skin), pustules, secondary infection, capillary fragility (ecchymoses), skin striae, skin atrophy

Rare

Hypertrichosis, sensitisation (mometasone)

Very rare

Pruritus

Not known

Dermatitis contact, skin hypopigmentation, dermatitis acneiform

General disorders and administration site conditions

Not known

Application site pain, application site reactions

Rare cases of hyperpigmentation have been reported in connection with other steroids and may therefore occur with Desmoson.

Local adverse reactions reported infrequently with topical dermatologic corticosteroids include: stinging, dry skin, skin irritation, perioral dermatitis, allergic contact dermatitis, skin maceration, miliaria and telangiectasia.

An increased risk of systemic effects and local adverse reactions exists with frequent dosing, treatment of large areas or in the long term and also the treatment of intertriginous areas or with occlusive dressings.

Paediatric population

Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than mature patients because of a larger skin surface to body weight ratio (see section 4.4).

Chronic corticosteroids therapy may interfere with the growth and development of children.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Excessive prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.

Reasonable symptomatic treatment should be initiated. If necessary, problems with the electrolyte balance must be treated.If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.

The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • ELOCOM 1 mg/g prescriptionMOMETASONUM · skin / topical
  • MOMETAZONA ATB 1 mg/g prescriptionMOMETASONUM · skin / topical

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Not the same combination. This medicine contains Mometasone furoate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

  • Eztom partial — not the same combinationMometasoni furoas · skin / topical
  • Mometaxon partial — not the same combinationMometasoni furoas · skin / topical

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

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Ask anything about Mometasone furoate 0.1%w/w Ointment. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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