Neutrogena T/Gel Therapeutic Shampoo

Neutrogena T/Gel Therapeutic Shampoo.

The shampoo contains Neutar solubilised coal tar extract 20mg/ml (equivalent to 5mg/ml coal tar) as the active ingredient. For a full list of excipients see section 6.1.

Shampoo.A translucent amber solution.

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 the active substance(s) or to any of the excipients listed in section 6.1. Acutely inflamed or broken skin, erythrodermic and generalized pustular psoriasis.

If irritation develops, discontinue use and consult a physician. Contact with eyes should be avoided.In rare instances, temporary discoloration of blond, 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 parahydroxybenzoates which may cause allergic reactions (possibly delayed).Contains esters of benzoic acid and benzyl benzoate which can mildly irritate the skin, eyes and mucous membranes.Contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

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 post-marketing experience with coal tar are presented in Table 1. In this table, the frequencies are provided according to the following convention:Very common ≥ 1/10Common ≥ 1/100 and < 1/10Uncommon ≥ 1/1,000 and < 1/100Rare ≥ 1/10,000 and < 1/1,000Very rare < 1/10,000Not known - cannot be estimated from the available data

Table 1: Adverse Drug Reactions Identified during Post-Marketing Experience with Coal Tar by Frequency Category estimated from Spontaneous Reporting Rates

Other Adverse Drug reactions identified in published literature include:

Skin and subcutaneous tissue disorders

Acne like skin eruptionsReporting 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

Not applicable.

Pharmacotherapeutic group: Medicated Shampoo, ATC code: D11 AC 30No new data are presented

No new data are presented

No new data are presented

Macrogol lauryl ether (4)Sodium lauryl ether sulfateCocodiethanolamideCocamidopropyl betaineImidazolidinyl ureaMethyl parahydroxybenzoate (E218)Propyl parahydroxybenzoate (E216)Tetrasodium EDTACitric acidFragrance FUGIO 242156Sodium chloridePurified water*The constituents of the fragrance include esters of benzoic acid, benzyl benzoate and butylated hydroxytoluene (E321).

Not applicable

3 years

Store away from direct sunlight. Do not store above 25°C.

Clear plastic bottle with plastic pop-up cap, or screw top, containing 15, 125, or 250 ml solution.Not all pack sizes may be marketed.

No special requirements.Any unused product or waste material should be disposed of in accordance with local requirements.

Johnson & Johnson LimitedFoundation ParkRoxborough WayMaidenheadBerkshireSL6 3UG

PL 08874/0014

Date of first authorisation: 30 April 1996 Date of latest renewal: 06 February 2004

26 June 2016