Summary of medicine characteristics - NEUTROGENA T/GEL THERAPEUTIC SHAMPOO
1 NAME OF THE MEDICINAL PRODUCT
Neutrogena T/Gel Therapeutic Shampoo.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3 PHARMACEUTICAL FORM
Shampoo
A translucent amber solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment for seborrhoeic dermatitis of the scalp, dandruff and scalp psoriasis.
4.2 Posology and method of administration
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.
4.3 Contraindications
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.
4.4 Special warnings and precautions for use
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, Anise Alcohol, Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Butylphenyl Methylpropional, Cinnamal, Cinnamyl Alcohol, Citral, Citronellol, Coumarin, Eugenol, Evernia Furfuracea (Treemoss) Extract, Evernia Prunastri (Oakmoss) Extract, Farnesol, Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Hydroxyisohexyl-3-Cyclohexene Carboxaldehyde, Hydroxyisohexyl 3-&4-Cyclohexene Carboxaldehyde (HMPCC), Isoeugenol, Limonene, Linalool and Methyl-2-Octynoate.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Adverse drug reactions (ADRs) identified during clinical trials and postmarketing 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 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.
4.9 Overdose
Not applicable.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Medicated Shampoo, ATC code: D11 AC 30
Coal tar suppresses DNA synthesis in hyperplastic skin by inhibiting mitotic activity and protein synthesis. It reduces epidermal proliferation and dermal infiltration, thus producing a return to normal hornification. Tar also has (cellular) proliferation-inhibiting, vasoconstrictive, antipruritic and antiseptic properties. This is of significance in the treatment of skin disease where there is increased cell partition, such as dandruff.
5.2 Pharmacokinetic properties
Little is known about the percutaneous absorption, residence time and excretion of coal tar, although there is an epidermal metabolism of polyaromatic hydrocarbons, and the urine of patients undergoing therapy with high levels of raw coal tar contains substances which apparently originate from the raw coal tars used. The potential for a systematic absorption of coal tar from shampoo is extremely low because it is washed off after use.
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol lauryl ether (4)
Sodium lauryl ether sulfate
Cocodiethanolamide
Cocamidopropyl betaine
Imidazolidinyl urea
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Tetrasodium EDTA
Citric acid
Fragrance FUGIO 242156
Sodium chloride
Purified water
*The constituents of the fragrance include esters of benzoic acid, benzyl benzoate, butylated hydroxytoluene (E321) and other allergens (refer to section 4.4).
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store away from direct sunlight. Do not store above 25°C.
6.5 Nature and contents of container
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.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Johnson & Johnson Limited
50 – 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
8 MARKETING AUTHORISATION NUMBER
PL 08874/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
Date of first authorisation: 30 April 1996
Date of latest renewal: 06 February 2004