Linotar – Patient Information Leaflet

PROPRIETARY NAME AND DOSAGE FORM:

LINOTAR GEL 1% Emulsion

COMPOSITION:

LINOTAR GEL 1 contains 1 g Coal Tar per 100 g = 10 mg/g; 1% w/w, wet weight).

Preservatives:

Sodium Propyl Paraben: 0.05 % m/m

Methyl Paraben: 0.1 % m/m

Vitamin E (DL-Alpha Tocopherol): 0.3 % m/m

Other ingredients:

Complex of esterified essential fatty acids; PEG-40 hydrogenated Castor Oil; Polysorbate 80; Xanthan Gum; Industrial Methylated Spirits; purified Water.

PHARMACOLOGICAL CLASSIFICATION:

A 13.9.1 Preparations for psoriasis

Coal Tar is an anti-pruritic.

INDICATIONS:

LINOTAR GEL 1 is used for:

  • The relief and treatment of PSORIASIS of the skin and scalp.
  • The relief and treatment of ECZEMATOUS conditions of the skin and scalp.
  • The relief of the symptoms of COLD SORES.

CONTRA-INDICATIONS:

Coal Tar sensitivity or allergy. Do not use on highly inflamed or broken skin.

WARNINGS AND SPECIAL PRECAUTIONS:

For external use only. Do not use this product in or around the rectum or genital area or groin. Avoid contact with the eyes. Upon accidental contact, flush eyes with water.

Special Precautions:

Coal Tar can enhance photosensitivity of the skin, and exposure to direct sunlight after application of LINOTAR GEL 1 should be avoided.

DOSAGE AND DIRECTIONS FOR USE:

To ensure adequate penetration of LINOTAR GEL 1, make sure the lesions are clean. Apply a thin layer of LINOTAR GEL 1 two to three times a day. Massage gently and leave to dry.

SIDE EFFECTS:

Coal Tar may cause irritation or acne-like eruptions of the skin. If irritation occurs, discontinue use and consult a doctor.

IDENTIFICATION:

A smooth mustard colored emulsion.

PRESENTATION:

Polyethylene squeeze bottles containing 250 ml of LINOTAR GEL 1.

STORAGE INSTRUCTIONS:

Store at or below 25 ?C

Keep out of reach of children

REGISTRATION NUMBER:

A 27/13.9.1/0357

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:

MeyerZall Laboratories (Pty) Ltd.

2nd Floor

121 Mitchell Street

George 6529, RSA

DATE OF PUBLICATION:

July 2015

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