Xalix

Name: Xalix

Clinical pharmacology

Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses.

Precautions

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. This product should not be allowed to contact normal skin surrounding the wart site, since localized irritation may occur. Treatment should be discontinued if excessive irritation occurs.

Dosage and administration

Prior to applying this product, soak wart in warm water for five minutes. Remove any loose tissue by gently rubbing with a washcloth, emery board, or pumice stone. Dry the wart site thoroughly. Using the brush applicator supplied, apply this product twice to the entire wart surface, allowing the first application to dry before applying the second. Continue treatment once or twice a day or as directed by a physician. Be careful not to apply to surrounding skin.

Clinically visible improvement normally occurs during the first or second week of therapy. Resolution may be expected after four to six weeks of this product’s use, though some warts may take longer to remove.

How supplied

10 g bottles, NDC 52187-525-10

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing and excessive heat. Keep bottle tightly closed.

Manufactured for:
KMM Pharmaceuticals, LLC
1000 N. West Street
Suite 1200, #1021
Wilmington, DE 19801

Xalix 
salicylic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52187-525
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 280 mg  in 1 g
Packaging
# Item Code Package Description
1 NDC:52187-525-10 1 BOTTLE, WITH APPLICATOR in 1 CARTON
1 10 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/25/2017
Labeler - KMM Pharmaceuticals, LLC (078521761)
Revised: 10/2017   KMM Pharmaceuticals, LLC
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