NIX® Creme Rinse

INDICATIONS

NIX® Creme Rinse is indicated for the treatment of infestation with head lice and their nits (eggs). This unique creme rinse leaves the hair manageable and easy to comb.

WHAT ARE HEAD LICE?

Head lice are small insects that live and feed on the human scalp causing itching and irritation. They range in colour from beige to black. Lice lay eggs, called nits, on the hair shaft close to the scalp. The nits are tiny, oval shaped and shiny, and range in colour from creamy white to brown. Nits normally hatch in 7 to 10 days. The adult lice cannot survive away from the head for much more than 24 hours.

HOW DOES A LICE INFESTATION SPREAD?

Head lice spread easily, primarily by close head-to-head contact with persons who have lice and occasionally by sharing personal articles such as clothing, hats, combs, hair accessories, towels and bed linen.

WHAT TO DO IF YOU OR A MEMBER OF YOUR FAMILY HAS HEAD LICE

Head lice affect millions of people each year, especially school-aged children. They do not transmit or cause disease and are not a sign of poor personal hygiene. A head lice infestation can be effectively treated with a topical pediculicide and ovicide treatment (a treatment effective at destroying lice and their eggs) such as NIX Creme Rinse.

DIRECTIONS FOR USE OF NIX® CREME RINSE

1. Wash the hair with conditioner-free shampoo. Do not use a conditioner. Rinse with water and towel dry thoroughly.
2. Shake NIX bottle well. Apply a sufficient amount of NIX (1/2 to 1 bottle) to thoroughly saturate the hair and scalp, especially behind the ears and at the base of the neck.
3. Leave NIX on the hair for 10 minutes.
4. Rinse NIX off hair with water.
5. Towel dry hair.
6. Comb hair with regular comb to remove tangles.
7. Remove nits: Part hair into sections; starting as close to the scalp as possible, remove the nits using the nit removal comb provided. Be sure to comb to the end of the hair shaft. The nit comb should be disinfected by soaking in hot water after each use. Inspect full head of hair thoroughly for any stray nits. The nit removal procedure should be repeated daily for the 7 days following treatment.

A single application is usually sufficient to eliminate a head lice infestation. The active ingredient in NIX persists on the hair for 10 days, even after subsequent washing with a conditioner-free shampoo. If you see live lice or nits after the first application, the residual effect should kill these. If you still see live lice or nits on the 7th day (or after) following the first application, NIX Creme Rinse should be applied a second time, as described above.

HOW TO HELP PREVENT REINFESTATION

Cleaning of personal articles is also an important part of head lice management and may help prevent reinfestation. Personal belongings including recently worn clothing, towels and bed linens should be machine washed in hot water and dried using the hot cycle of the dryer for at least 20 minutes. Personal articles of clothing or bedding that cannot be washed may be dry cleaned or sealed in a plastic bag for a period of two weeks. Combs and brushes should be disinfected by soaking in hot water (above 130°F/54°C) for 5 to 10 minutes.

Children should be advised not to use any borrowed combs or brushes, nor wear anyone else's clothes, especially hats.

Inspect all family members from time to time for any new lice infestation. If a new infestation is found treat with NIX Creme Rinse.

PRECAUTIONS

General: Head lice infestation is often accompanied by itching, redness, and swelling. Treatment with NIX may temporarily worsen these conditions. Do not use if allergic to any of its ingredients, synthetic pyrethroids or pyrethrin, or chrysanthemums. Discontinue use if reaction occurs.

Eye Irritation: NIX is not irritating to eyes; however, if it should get into them, rinse eyes immediately with water.

In Case of Swallowing: Consult your doctor or Poison Control Centre immediately.

Use in Pregnant or Nursing Women: There are no adequate or well-controlled studies in pregnant or nursing women. Consult a doctor before using this drug.

Use in Children: NIX is safe and effective in children two months of age and older. Safety and effectiveness in children less than two months of age have not been established. Consult your doctor.

Keep out of reach of children. To prevent accidental ingestion by children, the remaining contents of NIX should be discarded after use.

ADVERSE REACTIONS

In clinical studies, occasional itching has been known to occur. This is usually a consequence of head lice infestation itself, but may be temporarily worsened following treatment with NIX. Other reactions which are less frequent include: stinging/burning, tingling, numbness or discomfort, redness, and swelling or rash of the scalp. All these reactions are mild and temporary.

MEDICINAL INGREDIENT

Permethrin is the active ingredient in NIX Creme Rinse; it is present at a concentration of 1%.

NON-MEDICINAL INGREDIENTS (ALPHABETICALLY)

In addition, NIX Creme Rinse also contains the following non-active components: balsam Canada, cetyl alcohol, citric acid, FD&C Yellow No. 6, fragrance, hydrolyzed animal protein, hydroxyethylcellulose, isopropyl alcohol, parabens, polyoxyethylene cetyl ether, propylene glycol, stearalkonium chloride and water.

Comments or Questions ? 1-888-542-3546 or visit us at www.insightpharma.com
Distributed by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19049-1749

66621A