T/Gel® Shampoo T/Gel® Shampoo T/Gel® Shampoo 5 Mg/Ml Refined Coal Tar 5 Mg/Ml Refined Coal Tar 5 Mg/Ml Refined Coal Tar Read All of This Leaﬂet Carefully Because It 1

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T/Gel® Shampoo T/Gel® Shampoo T/Gel® Shampoo 5 mg/ml Refined Coal Tar 5 mg/ml Refined Coal Tar 5 mg/ml Refined Coal Tar Read all of this leaflet carefully because it 1. What Neutrogena T/Gel Shampoo is ! Pregnancy and breastfeeding contains important information for you. and what it is used for • Do not use if you are pregnant or breast feeding This medicine is available without prescription. ® ® unless recommended by your doctor. However you still need to use Neutrogena T/Gel Neutrogena T/Gel Shampoo is used to treat dandruff Shampoo carefully to get the best results from it. and seborrhoeic dermatitis (dry, flaking, itching scalp). ! Some of the ingredients can cause problems It contains the active ingredient refined coal tar. • Keep this leaflet. You may need to read it again. • This medicine contains parahydroxybenzoates which • Ask your pharmacist if you need more information or This medicine is for use in adults and children aged may cause allergic reactions (possibly delayed). advice. over 12 years. • This medicine contains esters of benzoic acid and • If irritation occurs, stop using the product and talk to benzyl benzoate which may be mildly irritating to your doctor or pharmacist. 2. Before you use Neutrogena T/Gel the skin, eyes and mucous membranes. • If you get any side effects, talk to your doctor or Shampoo • This medicine contains butylated hydroxytoluene pharmacist. This includes any possible side effects This medicine is suitable for most children and adults over which may cause local skin reactions (e.g. not listed in this leaflet. the age of 12 years but a few people should not use it. If contact dermatitis) or irritation to the eyes and you are in any doubt, talk to your doctor or pharmacist. mucous membranes. In this leaflet 1. What Neutrogena T/Gel Shampoo is and what it is X Do not use this medicine... • If you have ever had an allergic reaction (e.g. rash, 3. How to use Neutrogena T/Gel used for. Shampoo 2. Before you use Neutrogena T/Gel Shampoo swelling of the face and throat, difficulty breathing) to any of the ingredients. See Section 6. Adults and children aged 12 years and over. 3. How to use Neutrogena T/Gel Shampoo • In children under 12 years of age. 1. Wet hair thoroughly 4. Possible side effects • If you have inflammed or broken skin. 2. Apply Neutrogena® T/Gel® Shampoo and massage 5. How to store Neutrogena T/Gel Shampoo into the scalp. 6. Further information • If you have a rare and severe form of psoriasis causing redness, inflammation and blistering of 3. Leave lather on scalp for several minutes the skin (erythrodermic or pustular psoriasis). 4. Rinse ! Special warnings about this medicine 5. Repeat steps 2 and 3. • Avoid contact with eyes. If you do get 6. Rinse thoroughly Neutrogena® T/Gel® Shampoo in your eyes, bathe Use once or twice weekly or as recommended by them thoroughly with water. If the eyes become your dermatologist or doctor. irritated consult your doctor or pharmacist. If there is no improvement after 4 weeks • Temporary discoloration of grey, blonde, bleached consult your doctor or pharmacist. or tinted hair may occur.

T/Gel® Shampoo T/Gel® Shampoo T/Gel® Shampoo 5 mg/ml Refined Coal Tar 5 mg/ml Refined Coal Tar 5 mg/ml Refined Coal Tar Do not use the product for more than 4 weeks unless Reporting of side effects 6. Further information instructed to do so by your doctor. If you get any side effects, talk to your doctor, What is in the medicine? ® ® Neutrogena T/Gel Shampoo is for external use only. pharmacist or nurse. This includes any possible side ® ® effects not listed in this leaflet. You can also report The active ingredient in Neutrogena T/Gel If, however, you or your child accidentally swallows Refined coal tar 5 mg per ml. Neutrogena® T/Gel® Shampoo seek medical advice side effects directly via HPRA Pharmacovigilance, Shampoo is: right away. Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 Other ingredients are: Macrogol Lauryl Ether (4), 6764971; Fax: +353 1 6762517. Website: Sodium Lauryl Sulfate, Cocodiethanolamide, 4. Possible side effects www.hpra.ie; E-mail: [email protected]. Cocamidopropyl Betaine, Imidazolidinyl Urea, Methyl parahydroxybenzoate (E218), Propyl Like all medicines, Neutrogena T/Gel Shampoo can By reporting side effects you can help provide more parahydroxybenzoate (E216), Tetrasodium EDTA, cause side-effects, although not everybody gets them. information on the safety of this medicine. Citric Acid anhydrous, Perfume, Sodium Chloride and Effects which may occur include: Purified Water. • Swelling of the face, lips, mouth, tongue or throat 5. How to store Neutrogena T/Gel Shampoo What the medicine looks like which may cause difficulty in swallowing or breathing. Neutrogena® T/Gel® Shampoo is a translucent, amber Do not store above 25°C. If you experience any of these symptoms you should solution available in 125 ml or 250 ml bottles. seek medical advice immediately. Keep out of the sight and reach of children. Marketing Authorisation holder: • Allergic reactions including itchy rash and sensitivity Do not use after expiry date which is stated as ‘Exp Johnson & Johnson (Ireland) Ltd., Airton Road, to light. Date’ on the carton. The expiry date refers to the last Tallaght, Dublin 24, Ireland. • Hair loss or changes in hair colour. day of the month. Manufacturer: McNeil Products Ltd., Foundation • Eye irritation, acne like break outs or rash. Medicines should not be disposed of via wastewater Park, Roxborough Way, Maidenhead SL6 3UG, or household waste. Ask your pharmacist how to United Kingdom OR Purna Pharmaceuticals NV, • Application site reactions including skin irritation, dispose of medicines no longer required. These Rijksweg 17, 2870 Puurs, Belgium. burning sensation, itching and dry scalp. measures will help protect the environment. This leaflet was revised August 2017 If these side effects occur discontinue use and consult your doctor or pharmacist. Coal tar has been shown to increase the risk of skin tumours in animals. However, the risk for patients treated with coal tar is unclear. This product should only be used as directed and should not be used for prolonged 17-0461 periods, except under the instruction of your doctor. XXXXXX

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Job Bag No. 17-0461 PMS Proﬁle Version 1 543 Product Neutrogena Description PIL Country IRE Main body text Date 14/09/2017 SIZE: (PIL’s only) Manufacturer Purna 160 x 250 mm 9 pts Software Illustrator CS6 A print out of this image should not be used for exact colour matching but to check if the layout, spelling, text and colour references are correct. Please check thoroughly.