NIX CREME RINSE

01/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................

2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................

1 Pediatrics .......................................................................................................... 2 Geriatrics...........................................................................................................

4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION.................................................................................

1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment..................................................... 3 Reconstitution ...................................................................................................

4 Administration................................................................................................... 5 5 OVERDOSAGE .............................................................................................................

6

1 Adverse Reaction Overview 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® CRÈME RINSE. Other reactions which are less frequent include: stinging/burning, tingling, numbness or discomfort, redness, swelling or rash of the scalp, paraesthesia, eczema, skin oedema, skin irritation, smarting, and pain of skin.

All these reactions are usually mild and temporary. 1 Adverse Reaction Overview. 1 Clinical Trial Adverse Reactions – Pediatrics Information is not available. 3 Less Common Clinical Trial Adverse Reactions Information is not available.

1 Less Common Clinical Trial Adverse Reactions – Pediatrics Information is not available. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Information is not available. 5 Post-Market Adverse Reactions Information is not available.

, Pregnant Women and 7 WARNINGS AND PRECAUTIONS, Breast-feeding ).  Patients allergic to any of the ingredients, synthetic pyrethroids or pyrethrin, or chrysanthemums should not use the drug (see 7 WARNINGS AND PRECAUTIONS, General).

1 Dosing Considerations  A single application is usually sufficient to eliminate a head lice infestation. The active ingredient in NIX® CRÈME RINSE 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® CRÈME RINSE should be applied a second time.

Product Monograph <NIX® CRÈME RINSE ><Permethrin cream 1%> Page 5 of 16  Cleaning of personal articles is also an important part of head lice management and may help prevent reinfestation. Personal belonging 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® CRÈME RINSE.

1 Dosing Considerations. 3 Reconstitution Not applicable. 4 Administration Directions Adults and children 2 years of age and over: 1. Wash the hair with conditioner-free shampoo. Do not use conditioner. Rinse with water and towel dry thoroughly.

 NIX® CRÈME RINSE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.