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Logo PARA SPECIAL LICE SPRAY

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

PARA SPECIAL LICE SPRAY

COMPOSITION:
Each 140 mL contains:

Bioallethrin         0.660g
Piperonyl Butoxide         2.640g

PHARMACOLOGICAL CLASSIFICATION:
A32.7 Topical applications of delousing agents.

PHARMACOLOGICAL ACTION:
This is an anti-parasitical preparation based on bioallethrin (a synthetic pyrethroid) and piperonyl butoxide which is used for its synergistic action. It is effective against lice and their nits.

INDICATIONS:
PARA SPECIAL LICE SPRAY is indicated in both the preventative and the curative treatment of human pediculosis, Pediculus capitis (head lice). In order to avoid any risk of re-infestation PARA should be sprayed on contaminated clothes, hats and scarves.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.

WARNING:
  Only use this product as directed. Misuse or improper use may lead to intolerance. A stinging sensation may be experienced if applied to broken skin or in the presence of allergy. If this should occur, rinse the hair immediately, and discontinue use.
  Do not inhale aerosol gases.
  FOR EXTERNAL USE ONLY.
  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 using brief puffs without prolonged spraying. Spray the aerosol in a well ventilated room, and air well after use.

DOSAGE AND DIRECTIONS FOR USE:
Before use, test for sensitivity on a small patch of skin on the inner arm.
(a) Curative treatment:
In order to obtain maximum efficiency, it is important to cover the scalp with PARA SPECIAL LICE SPRAY since the lice and nits are usually situated at the base of the hair, i.e. in contact with the skin. The tip of the aerosol tube must thus be inserted into the thickness of the hair with spraying by brief pressure for approximately one second at the root of the hair and frequently changing the site until the zone to be treated is completely covered (5 –10 sprayings according to the length and thickness of hair). Do not cover head with a bonnet or towel. In order to eliminate dead parasites, wash the hair with your usual shampoo thirty minutes after PARA SPECIAL LICE SPRAY curative application. Then, detach dead nits using a fine comb. To avoid any risk of re-infestation, do not forget to disinfect contaminated clothing, hats or scarves. For this purpose it is sufficient to spray PARA SPECIAL LICE SPRAY holding the aerosol approximately twenty centimeters away from the garments.
(b) Preventative treatment:
PARA SPECIAL LICE SPRAY is of value in preventing lice infestation when there is a risk. In order to be protected against lice it is not necessary to saturate the scallop completely. It is sufficient to lightly spray PARA SPECIAL LICE SPRAY every three days onto hair (3 to 5 sprayings according to the hair length and thickness), until the epidemic has disappeared. Wash hair once a day +8 hours after application.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Ocular and respiratory tract irritation may occur, if PARA SPECIAL LICE SPRAY is accidentally inhaled. Inhalation of aerosol gases should be avoided. Use with caution in asthmatic patients. Prolonged contact may eventually lead to dermatitis.

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-histamines and/or apply mild topical cortisone to scalp. PARA SPECIAL LICE SPRAY inhaled in large quantities, irritates the tracheo-broncial 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 case of accidental ingestion, spasms, respiratory distress, ptosis of the eyelid may occur. Management of overdosage and poisoning is symptomatic.

IDENTIFICATION:
A clear, pale yellowish liquid with a petroleum odour.

PRESENTATION:
A 140 mL aerosol container.

STORAGE INSTRUCTIONS:
KEEP OUT OF REACH OF CHILDREN.
Store below 25°C.
The package is conditioned under pressure, therefore: Store away from any naked flame, heat source or operating electrical appliance. Do not expose to the sun’s rays. Do not pierce or throw into fire even when empty. Do not spray in the direction of a flame or fire.

REGISTRATION NUMBER:
P/13.4.2/115

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:
9 August 1982

Manufactured under Licence to Pharygiene S.C.A.T. (France

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

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