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NEUTROGENA T/GEL THERAPEUTIC SHAMPOO

Active substance(s): NEUTAR SOLUBILISED COAL TAR EXTRACT / NEUTAR SOLUBILISED COAL TAR EXTRACT / NEUTAR SOLUBILISED COAL TAR EXTRACT

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SUMMARY OF PRODUCT CHARACTERISTICS

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 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.

4.4

Special warnings and precautions for use
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.

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 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 ≥ 1/10
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
Table 1: Adverse Drug Reactions Identified During Post-Marketing Experience
with Coal Tar by Frequency Category estimated from Spontaneous Reporting
Rates
Body system
Immune System
Disorders

Incidence
Not known

Skin and
Subcutaneous
Disorders
General Disorders
and Administrative
Site Conditions

Not known

Not known

Reported adverse event
Angioedema
Hypersensitivity (including
Urticaria,
Photosensitization)
Hair loss
Dry Hair
Rash
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
Acne like skin eruptions
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

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Medicated Shampoo, ATC code: D11AC30
No new data are presented

5.2

Pharmacokinetic properties
No new data are presented

5.3

Preclinical safety data
No new data are presented

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
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
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
27/06/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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