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

Logo PARA PLUS LICE SPRAY

SCHEDULING STATUS:
Schedule 1.

PROPRIETARY NAME
(and dosage form):

PARA PLUS LICE SPRAY

COMPOSITION:
Each gram contains:

Malathion         0.0025g
Permethrin         0.0050g
Piperonyl Butoxide         0.0200g

PHARMACOLOGICAL CLASSIFICATION:
A 34.7 Topical applications of delousing agents.

PHARMACOLOGICAL ACTION:
The preparation Permethrin, Piperonyl butoxide and Malathion is a pediculicide which acts on both nits and hatched lice.

INDICATIONS:
Treatment of human pediculosis capitis (head lice).

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Do not use on children under the age of 30 months.

WARNING:
FOR EXTERNAL USE ONLY.
Allergic reactions and skin sensitivity may occur. Avoid application to broken skin. A stinging sensation may be experienced if applied to broken skin or in the presence of allergy. If this should occur, discontinue use, wash hair thoroughly with a regular shampoo and rinse hair with plenty of water. Use and store away from any naked flame, heat source or operating electrical appliance.
Keep the treated person away from any naked flame or heat source while spraying and while the hair is impregnated with product. Do not smoke while spraying, handling, or while the hair is impregnated with product. Spray brief puffs without prolonged spraying. Spray the aerosol in a well ventilated room and air well after use. Do not inhale aerosol gasses.

INTERACTIONS:
If you are currently taking or using other medicines, concomitant use of this product may cause undesirable interactions. Please consult your doctor or pharmacist.

PREGNANCY OR LACTATION:
The use of this product is contra-indicated in pregnant or lactating females.

DOSAGE AND DIRECTIONS FOR USE:
Before use, test for sensitivity on a small patch of skin on the inner arm. Use the aerosol tube to direct the spray onto the base of the hair shaft. Use short one second sprays until the scalp and hair base are moist. DO NOT LEAVE ON THE HAIR FOR LONGER THAN 10 MINUTES.
Wash the hair with a regular shampoo and rinse well. Eliminate dead lice and nits by means of a fine-tooth comb. To avoid any recontamination, also disinfect the clothes and bedding. ONE APPLICATION IS SUFFICIENT PER INFESTATION.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The following side-effects have been reported: Pruritis, burning sensation of the skin and an ocular prickling sensation. Ocular and respiratory tract irritation may occur. If PARA PLUS LICE SPRAY is accidentally inhaled.
Special Precautions: The sprayings should be carried out in a well aerated place, far from any flame. Avoid contact with mucosa and eyes. Keep the mouth and eyes closed during spraying. Do not swallow. Do not use on children under the age of 30 months. Inhalation of aerosol gases must be avoided in asthmatic patients.
KEEP OUT OF REACH OF CHILDREN.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment of topical allergic reaction is supportive and symptomatic. Wash hair thoroughly with a regular shampoo and rinse hair and scalp with plenty of water. If required to relieve skin irritation, administer anti-histamins and/or apply mild topical cortisone to scalp. PARA PLUS LICE SPRAY inhaled in large quantities, irritates the tracheo-bronchial mucous membranes, the conjunctiva, the nose and mouth mucous membranes.
Aerosol propellants have been subject to deliberate abuse. Propane and butane can act as simple asphyxiants. Treatment is symptomatic and supportive. In the event of accidental ingestion, symptoms of systemic toxicity of Malathion may be delayed for up to 12 hours and may include: abdominal cramps; anxiety or restlessness; confusion or mental depression; trembling; unusual weakness; diarrhea; dizziness; drowsiness; increased watering of the mouth or eyes; loss of bowel or bladder control; muscle twitching of eyelids, face and neck; pinpoint pupils; respiratory distress; seizures; slow heartbeat.
Significant systemic absorption of Malathion may bring on an asthma attack in asthmatic patients.
Treatment of systemic toxicity: Management of overdosage and poisoning is symptomatic and a doctor must be consulted immediately as rapid treatment is essential. If organophosphates have been ingested the stomach should be emptied by lavage. Atropine should be administered to counteract the symptoms of cholinesterase depletion. Obidoxine may be used, as an adjunct to Atropine and supportive measures, to reverse muscle paralysis. Diazepam may be given to control convulsions. Plasma and red blood cell cholinesterases should be monitored. The patient must be monitored for signs of deterioration due to delayed absorption.

IDENTIFICATION:
A colourless or pale yellow liquid with a characteristic odour.

PRESENTATION:
Pressurised solution supplied in an aluminium container filled to 90g.

STORAGE INSTRUCTIONS:
Store below 25°C. The aerosol container is conditioned under pressure. Protect from sunlight. Do not pierce or throw into fire even when empty. Store away from any naked flame, heat source or operating electrical appliance.

REGISTRATION NUMBER:
29/13.4.2/0243

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
TECHNIKON LABORATORIES (PTY) LTD
1073 Anvil Road, Robertville, Florida. Tel: (011) 674-1091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
03/06/1999

New addition to this site: February 2007
Source: Pharmaceutical Industry

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