Nix Complete Lice Treatment Kit
NDC Package 63736-035-01

11-digit billing NDC: 63736003501

Package Information

Nix Complete Lice Treatment (permethrin) kits is important: Read warnings before useAdults and children 2 months old and olderInspectall household members should be checked by another person for lice and/or nits (eggs)use a magnifying glass in bright light to help you see the lice and/or nits (eggs)use a tool, such as a comb or two unsharpened pencils to lift and part the hairlook for tiny nits near scalp, beginning at back of neck and behind earssmall sections of hair (1-2 inches wide) should be examined at a timeunlike dandruff, nits stick to the hair. This formulation utilizes a kit delivery system. Marketed by Insight Pharmaceuticals Llc, this product is identified by NDC 63736-035 and is authorized under FDA application NDA019918.

Identification & Billing

NDC Package Code
63736-035-01
Package Description
1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 147.86 mL in 1 BOTTLE * 2 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE
Product Code
11-Digit Billing Format
63736003501

Clinical Specifications

Proprietary Name
Nix Complete Lice Treatment
Non-Proprietary Name
Permethrin
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Important: Read warnings before useAdults and children 2 months old and olderInspectall household members should be checked by another person for lice and/or nits (eggs)use a magnifying glass in bright light to help you see the lice and/or nits (eggs)use a tool, such as a comb or two unsharpened pencils to lift and part the hairlook for tiny nits near scalp, beginning at back of neck and behind earssmall sections of hair (1-2 inches wide) should be examined at a timeunlike dandruff, nits stick to the hair. Dandruff should move when lightly touched,if either lice or nits (or eggs) are found, treat with Nix® Creme RinseTreatwash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix®. Rinse with water.towel dry hair so it is damp but not wetshake the bottle of Nix® wellcompletely saturate the hair and scalp with Nix®. Begin to apply Nix® behind the ears and at the back of the neck.keep Nix® out of the eyes. Protect the eyes with a washcloth or towel.leave Nix® on the hair for 10 minutes, but no longerrinse with warm watertowel dry hair and comb out tanglesif live lice are seen seven days or more after the first treatment, a second treatment should be givenRemove Lice/Nitsremove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.use the nit comb provided and make sure the hair remains slightly damp while removing nitsif the hair dries during combing, dampen it slightly with waterpart the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).start at the top of the head on the section you have pickedwith one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.use clips to pin back each strand of hair after you have combed out the nitsclean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.after combing, recheck the entire head for nits and repeat combing if necessarycheck the affected head daily to remove any nits that you might have missed use after shampooing with lice killing creme rinsetowel dry hairapply combining gel until all the hair and scalp is thoroughly wet with productmake sure product covers the area behind the ears and at the nape of the neck where there are more likely to be nitspart hair into sections and clip backuse the enclosed special-toothed comb to comb out dead lice and nitscomb out one section at a timeit is extremely important to comb out dead lice and nitsif hair begins to dry, reapply additional productwhen you finish combing, rinse hair thoroughly with warm water. 

Regulatory & Marketing

Labeler Name
Insight Pharmaceuticals Llc
Product Type
Human Otc Drug
FDA Application #
NDA019918
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-15-2013
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63736-035-01 identifies a specific commercial package of 1 kit in 1 carton * 1 bottle in 1 carton / 59 ml in 1 bottle * 1 bottle in 1 carton / 147.86 ml in 1 bottle * 2 bottle in 1 carton / 59 ml in 1 bottle of Nix Complete Lice Treatment, a human over the counter drug labeled by Insight Pharmaceuticals Llc. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Insight Pharmaceuticals Llc on November 15, 2013. The current certification is valid through December 31, 2027.

How is this Insight Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63736003501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63736-035-01
11-Digit CMS (5-4-2)
63736-0035-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.