INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo QUELLADA APPLICATION P.C. SHAMPOO

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME:
(and dosage form)

QUELLADA APPLICATION P.C. SHAMPOO

COMPOSITION:
Contains 1% (m/m)
gamma benzene hexachloride in a liquid shampoo base.

PHARMACOLOGICAL CLASSIFICATION:
A 13.1 Antiseptics, disinfectants, cleansing agents.

PHARMACOLOGICAL ACTION:
Gamma benzene hexachloride is a powerful inducer of microsomal enzymes. This property makes it an effective insecticide, larvicide and acaricide.

INDICATIONS:
QUELLADA APPLICATION P.C. is used for the destruction and elimination of head lice, pubic lice (crab lice) and their eggs from the head or other hairy parts of the body.

CONTRA-INDICATIONS:
Not for use in premature neonates.

DOSAGE AND DIRECTIONS FOR USE:
Treatment of Head Lice:
Before use wet hair thoroughly with warm water and wring excess water out by hand. About 30 mL (2 tablespoonsful) of the application should be poured onto the head, paying particular attention to cover the scalp and the hair close to the scalp. The application should be worked thoroughly into the hair and scalp and allowed to remain in place for four minutes. Small quantities of water should be added until a good lather forms. The hair should be rinsed thoroughly and towelled briskly. Any remaining eggs or nit shells may be removed by fine tooth combing or with tweezers. Used towels should be replaced after treatment to prevent re-infestation. Repeat if necessary after 24 hours.

Treatment of Pubic Lice: The hair should be wet thoroughly and enough of the application applied to cover all affected areas. The hair should be rubbed vigorously for at least four minutes and then rinsed thoroughly and towel-dried. One application is usually sufficient, but treatment may be repeated after seven days. Treatment should not be repeated within a 24 hour period.

For external use only.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gamma benzene hexachloride is a chlorinated insecticide and can produce symptoms consistent with central nervous system stimulation. It may be absorbed through the respiratory and gastrointestinal tracts and through the skin. It is a powerful inducer of microsomal enzymes. QUELLADA APPLICATION PC. should not be allowed to come into contact with the eyes, nose, mouth or other delicate membranes. Application to broken skin or large areas should be avoided as it may give rise to skin reactions. Should lather accidentally get into the eyes, it should be flushed out immediately with water. QUELLADA APPLICATION P.C. should not be used more than twice in any one week. Do not use as a routine shampoo.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Poisoning could occur, through accidental ingestion, innaiation or percutaneous absorption.
Symptoms: Symptoms of acute poisoning include nausea and vomiting, diarrhoea, parasthesia, respiratory failure, giddiness and fatigue, followed by tremors, convulsions and coma. Liver, kidney and myocardial toxicity have also been reported with chlorinated pesticides, while effects on the blood include agranulocytosis and aplastic anaemia. Early symptoms are loss of appetite, muscular weakness, fine tremors and an apprehensive mental state.

TREATMENT OF OVERDOSAGE:
Acute poisoning (ingestion):
Emesis should be induced with syrup of ipecac unless the patient is comatose or has lost the gag reflex when gastric lavage should be performed, followed by activated charcoal and then sodium or magnesium sulphate cathartics. Do not administer sympathomimetics, atropine or oils. Artificial respiration may be indicated to counteract pulmonary failure. Convulsions may be treated with i.v. diazepam.
Chronic poisoning (topical) may occur when patients use the product regularly (misuse), or apply the shampoo regularly to others without gloves. The patient should be withdrawn from the product.

IDENTIFICATION:
Clear yellow liquid.

PRESENTATION:
Supplied in amber glass bottles of 100 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 30°C).
Keep out of reach of children.

REGISTRATION NUMBER:
J/13.1/60

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
G.D. Searle (South Africa) (Pty) Ltd
14 Mandy Road
Reuven
Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 February 1976

Under licence from: Stafford-Miller Ltd., Welwyn Garden City, Herts, England

        Code 4350(9/93)-5-10/93
Rosside 23985

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