Neutrogena T/Gel Therapeutic Shampoo

Summary of Product Characteristics Updated 02-Feb-2021 | Johnson & Johnson Ltd

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 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.

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 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.

4.9 Overdose

Not applicable.

5. Pharmacological properties
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

Effects in non-clinical studies were observed only at exposures considered sufficiently in, excess of, the maximum human exposure indicating little relevance to clinical use.

Coal tar contains certain chemicals that are mutagenic and high dose administration of coal tar to laboratory animals is carcinogenic. However, epidemiological evidence from patients receiving coal tar therapy do not suggest a potential for an increased risk of skin or systemic cancer.

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 and butylated hydroxytoluene (E321).

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 and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

Johnson & Johnson Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

8. Marketing authorisation number(s)

PL 08874/0014

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 30 April 1996

Date of latest renewal: 06 February 2004

10. Date of revision of the text

18 January 2021

Company Contact Details
Johnson & Johnson Ltd
Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG, UK

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