Lindane Lotion - Scabicide

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Lindane Lotion - Labelling Standard

Lindane Cream and Lotion USP XXII

Category: Scabicide

Definition

Medicianl Ingredients and Concentrations

All finished product and ingredients used in the manufacture of the product should comply with the specifications of Schedule B pharmacopoeial or equivalent standard.

The medicinal ingredients of a product complying with this standard consist of the following ingredient when used singly or in acceptable combinations within the established limits given:

• Lindane (gamma benzene hexachloride) 1%

Permitted Combinations

Adequate Directions for Use:

Indications: For the treatment of scabies (Sarcoptes scabiei)

Dosage Directions:

1. Shake bottle well before use (for lotion only).
   
   
2. Read package insert carefully before using this product. (applicable only if all information cannot be included on the labels)
   
   
3. Apply a thin layer of cream or lotion to the entire body from chin to toes, paying special attention to creases in the skin, hands, feet (including the soles), between fingers and toes, and moist areas such as underarms and groin. Rub in well.
   
   
4. If applying after a warm bath or shower, dry body thoroughly and let cool down before using this product.
   
   
5. Put on clean clothes. Long sleeve shirts, pants and mittens should be worn by young children to prevent any contact of the treated skin with the mouth.
   
   
6. leave lotion on for 8-12 hours for adults (ie. overnight) and 6-8 hours for children. If hands are washed, the lotion should be reapplied after washing.
   
   
7. After 8-12 hours for adults (ie. overnight) and 6-8 hours for children, take a bath or shower, washing thoroughly all areas of application.
   
   
8. Change into freshly laundered clothes using only freshly laundered towels and bed clothes.
   
   
9. A single application may be successful but the procedure should be repeated once seven days after the first application if evidence of infestation persists (eg. live mites appear or new lesions develop). Itching may persist for one to several weeks after successful treatment. This reaction does not indicate treatment failure and is not an indication for further treatment with lindane.

Warnings:

1. FOR EXTERNAL USE ONLY.
   
   
2. Avoid contact with eyes, nose, mouth and other mucous membranes as well as wounds and broken skin.
   
   
3. If accidental contact with eyes does occur, flush eyes with water and seek prompt medical attention.
   
   
4. If product is accidentally swallowed, consult a physician or contact poison control centre.
   
   
5. Any signs of nausea, vomiting, headache or restlessness in children should be reported to a physician.
   
   
6. If skin irritation occurs, discontinue use, wash treated skin with soap and water and consult a physician.
   
   
7. Should not be used on infants, children under 6 years of age, pregnant women or nursing mothers or the elderly with a history of seizure activity except on the advice of a physician, nurse or pharmacist.
   
   
8. Persons liable to treat two or more persons in the same year should use rubber/plastic gloves when using lindane products (shampoos, creams, lotions).
   
   
9. Discontinue use of other topical medications and cosmetics while treating.
   
   
10. These infestations are spread by contact; all members of the household and sexual partner should be carefully examined and treatment instituted where necessary to prevent spread of infestation.
    
    
11. Spread and re-infestation are common. To prevent this from happening, all clothing, towels, bedding etc. should be washed in very hot water and by using the hot cycle in the dryer for at least 20 minutes. Dry cleaning should suffice for blankets, jackets and other non-washables. Mattresses which have been used by an infested person should not be used for 48 hours. Toilet seats, combs etc. should be dis- infected by washing with lindane, being careful to rinse thoroughly.

NOTE: This labelling standard describes those requirements that are specific to this class of drugs. Other requirements described in the Regulations to the Food and Drugs Act and in the Guide for the Labelling of Drugs for Human Use should also be met.

References

1. USPDI, Drug Information for the Health Care Professional, Ninth Edition, 1989.
2. AHFS Drug Information '89, American Society of Hospital Pharmacists, 1989.
3. Self Medication, A Reference for Health Professionals, Canadian Pharmaceutical Association, Third Edition, 1988.

Product Regulation Division
Bureau of Nonprescription Drugs
created:89-08-11
revised:89-12-12