Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Coal tar extract may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Neutrogena® T/Gel® Therapeutic Shampoo is a fragranced medicated shampoo which should be used two or three times a week, for the treatment of itchy, flaky scalp disorders such as dandruff, psoriasis and seborrhoeic dermatitis. Regular use for up to 6 weeks will help to control these problems. The shampoo can be used by adults and children aged 12 years and over.
FONTS USED
LARGEST TEXT SIZE
41.70 pt
AVE. TEXT SIZE
HelveticaNeue-Bold HelveticaNeueLTStd-Cn HelveticaWorld-Bold HelveticaWorld-Regular ZapfDingbatsStd
Braille Grid
8.4983 pt
SMALLEST TEXT SIZE
4.00 pt
Tamper Evident Label Area Seal Area Varnish Free Print & Varnish Free Coding (Silent Zone)
Print Free
Stamping Area Perforation Text Limit Profile
TECHNICAL DETAILS
WHITE Substrate
Bleed
Fold/Technical
Date 09-02-2022 Master Dieline
148 x 350 mm Dimensions
Purna Plant
Leaflet Component
Technical Code 148x350_148x35-2_210105_MPS_CUTTER_GUIDE_ 03500148P00350148L02-M040U5005
Reference
Colours represented with a diagonal line have been modified to aid PDF approval.
MANUFACTURING SITE
LITHO OFFSET LITHO OFFSET
REPRESENTATION:
PANTONE 543 C Black
JJEXT_00097_V2
Date 16-08-2023
English
403408950_r0 Job / Version No.
Languages
206636 LC61 Old Component / Item Code
EMEA_2023_00051332_001 ArtWorks ID
XXXXXX New Component / Item Code
Product / Eurocode / Mat. ID Code XXXXXX
CHILD
Project Name / Design GB_NTG_T/Gel Therapeutic Shampoo_all sizes_PIL Purna_Update Fragrance
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ing this medicine. 3. How to use this medicine. 4. Possible side-effects. 5. How to store this medicine. 6. Further information.
Special Warnings about this product
If contact with eyes occurs rinse thoroughly with water. Coal tar may cause your skin to react to sunlight after use, so you should avoid direct sunlight immediately after use. ■ In rare cases, there may be temporary discolouration of grey, blonde, bleached or tinted hair. ■ If irritation develops, discontinue use. ■ ■
If any of the above applies to you, talk to your doctor or pharmacist.
Pregnancy and Breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Some of the ingredients can cause problems
Methyl (E218) and Propyl (E216) parahydroxybenzoate may cause allergic reactions which could be delayed. This medicine contains fragrances with the following components which may cause allergic reactions: Alpha-Isomethyl-ionone, Amyl Cinnamal, AmylCinnamyl Alcohol, Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Cinnamal, Cinnamyl Alcohol, Citral, Citronellol, Eugenol, Farnesol, Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Isoeugenol, Limonene and Linalool. ■ Esters of benzoic acid, benzyl benzoate and butylated hydroxytoluene (E321) may cause local skin reactions (e.g contact dermatitis), or irritation to the eyes and mucous membranes. ■
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Neutrogena® T/Gel® Therapeutic Shampoo Use this medicine only on your scalp.
Applying the Shampoo 1) Wet hair thoroughly. 2) Apply liberal amounts of shampoo and massage into the scalp to form a rich lather. 3) Leave the lather on the scalp for several minutes. 4) Rinse and repeat the application once more. 5) Rinse thoroughly, avoiding contact with eyes.
Children under 12 years of age
Should not be used by children under 12 years of age.
Adults and children aged 12 years and over
Apply the shampoo as described above two or three times a week. ■ ■
Treatment should last about 6 weeks. If there is no improvement after 6 weeks consult your doctor or pharmacist. If irritation develops, stop using the shampoo and contact your doctor if necessary.
If you anyone has swallowed this product
If you or your child accidentally swallows Neutrogena® T/Gel® Therapeutic Shampoo, contact a doctor or your nearest accident and emergency department (Casualty) right away, taking this pack with you.
Like all medicines, this product can cause side-effects, although not everybody gets them.
XXXXXX XXXX
Effects which may occur include: ■ Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. ■ Allergic reactions including itchy rash and sensitivity to light. ■ Dry hair, hair loss or changes in hair colour. ■ Eye or skin irritation, burning sensation, itching, dry scalp, acne like breakouts or rash.
Reporting of side-effects
If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple Store. By reporting side-effects you can help provide more information on the safety of this medicine.
Neutrogena® T/Gel® Therapeutic Shampoo
Keep this medicine out of the sight and reach of children. Do not use the shampoo after the expiry date printed on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. Do not store this product above 25°C. Store away from direct sunlight.
6 Further information What's in this medicine?
The active ingredients is: NeutarTM Solubilised Coal Tar Extract 20 mg/ml. Other ingredients are: Macrogol lauryl ether (4), Sodium lauryl ether sulfate, Cocodiethanolamide, Cocamidopropylbetaine, Imidazolidinyl urea, Methyl parahydoxybenzoate (E218), Propyl parahydroxybenzoate (E216), Tetrasodium EDTA, Citric acid anhydrous, Perfume (contains esters of benzoic acid, benzyl benzoate, butylated hydroxytoluene (E321) and other known allergens [refer to section 2]), Sodium chloride and Purified water.
What the medicine looks like and contents of the pack
Neutrogena® T/Gel® Therapeutic Shampoo is a translucent amber solution. This product is available in pack sizes of 125 ml, 250 ml and 2 x 250 ml. Not all pack sizes may be marketed. Marketing Authorisation holder: Johnson & Johnson Limited, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK. Manufacturer: Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium. This leaflet was revised August 2023. Neutrogena® T/Gel® is a registered trade mark. © Johnson & Johnson Limited 2023.
Neutrogena T/Gel Therapeutic Shampoo comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Neutrogena T/Gel Therapeutic Shampoo is coal tar extract.
This leaflet reproduces the patient information leaflet approved for Neutrogena T/Gel Therapeutic Shampoo, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment for seborrhoeic dermatitis of the scalp, dandruff and scalp psoriasis.
Posology
Liberal amounts of Neutrogena T/Gel Therapeutic Shampoo should be applied and massaged into the wet scalp and left for several minutes. The scalp should be rinsed, the application repeated and then the scalp rinsed thoroughly. Neutrogena T/Gel Therapeutic Shampoo should be used two to three times weekly for the treatment of scalp disorders.
Treatment usually lasts for 6 weeks, after which time improvement should be seen. Longer periods of treatment should only take place under the supervision of a doctor.
Paediatric population
Neutrogena T/Gel Therapeutic shampoo is not recommended for use in children below 12 years of age due to insufficient data on safety and efficacy in this age group.
Method of administration
For cutaneous use only.
Hypersensitivity to coal tar or to any of the excipients listed in section 6.1.
Acutely inflamed or broken skin, erythrodermic or generalized pustular psoriasis.
If irritation develops, discontinue use and consult a physician.
Contact with eyes should be avoided. If contact occurs, rinse eyes thoroughly with water.
In rare instances, temporary discoloration of grey, blonde, bleached or tinted hair may occur.
Coal tar may have a photosensitising action and caution should be exercised in exposing skin to sunlight after use.
Contains Methyl (E218) and Propyl (E216) parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Esters of benzoic acid, benzyl benzoate and butylated hydroxytoluene (E321) may cause local skin reactions (e.g contact dermatitis), or irritation to the eyes and mucous membranes.
This medicine contains fragrance with the following components which may cause allergic reactions: Alpha-Isomethyl-ionone, Amyl Cinnamal, AmylCinnamyl Alcohol, Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Cinnamal, Cinnamyl Alcohol, Citral, Citronellol, Eugenol, Farnesol, Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Isoeugenol, Limonene and Linalool.
No interaction studies have been performed.
There are no studies to demonstrate the safety of Neutrogena T/Gel Therapeutic Shampoo in human pregnancy.
It is recommended that Neutrogena T/Gel Therapeutic Shampoo is not used during pregnancy or while breast-feeding, unless the risks and benefits have been evaluated and discussed with a physician.
Not relevant.
Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with coal tar are listed below by System Organ Class (SOC). The frequencies are provided according, to the following convention:
Very common ≥ 1/10
Common ≥ 1/100 and < 1/10
Uncommon ≥ 1/1,000 and < 1/100
Rare ≥ 1/10,000 and < 1/1,000
Very rare < 1/10,000
Not known - cannot be estimated from the available data
ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.
System Organ Class (SOC)
Frequency
Adverse Drug Reaction (Preferred Term)
Immune System Disorders
Not known
Hypersensitivity (including Urticaria, Photosensitization)
Eye Disorders
Not known
Eye irritation
Skin and Subcutaneous Tissue Disorders
Not known
Angioedema
Dry hair
Hair colour changes
Hair loss
Rash
General Disorders and Administrative Site Conditions
Not known
Application site reactions (including burning sensation, irritation, pruritus and dry scalp)
Other Adverse Drug Reactions identified in published literature include:
Skin and subcutaneous tissue disorders
Dermatitis acneiform
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
Ask anything about Neutrogena T/Gel Therapeutic Shampoo. 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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