Systeme Biolage Anti-Dandruff Shampoo is a topical preparation containing 27.5% Systeme Biolage Anti-Dandruff Shampoo in a proprietary film-forming vehicle that comprises isopropyl alcohol, butyl acetate, polyvinyl butyral, isopropyl metacresol, trimethyl pentanyl diisobutyrate, phenic acid and acrylates copolymer. The pharmacologic activity of Systeme Biolage Anti-Dandruff Shampoo is generally attributed to the keratolytic activity of Systeme Biolage Anti-Dandruff Shampoo which is incorporated into a polyacrylic, film-forming virucidal vehicle designed to cover the wart without the need for a bandage. The structural formula of Systeme Biolage Anti-Dandruff Shampoo is:

CLINICAL PHARMACOLOGY

Although the exact mode of action for Systeme Biolage Anti-Dandruff Shampoo 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.

The virucidal complex incorporated into Systeme Biolage Anti-Dandruff Shampoo’s proprietary vehicle is designed to help reduce risk of reinfection at the wart site, as well as prevent viral contamination of the product under normal usage.

INDICATIONS AND USAGE

Systeme Biolage Anti-Dandruff Shampoo is indicated for the topical treatment and removal of common warts and plantar warts.

CONTRAINDICATIONS

Patients with diabetes or impaired blood circulation should not use Systeme Biolage Anti-Dandruff Shampoo. Systeme Biolage Anti-Dandruff Shampoo also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.

PRECAUTIONS

Systeme Biolage Anti-Dandruff Shampoo is for external use only. Do not permit Systeme Biolage Anti-Dandruff Shampoo to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Systeme Biolage Anti-Dandruff Shampoo should not be allowed to contact normal skin surrounding wart, since localized irritation may occur. Treatment should be discontinued if excessive irritation occurs. Systeme Biolage Anti-Dandruff Shampoo is flammable. Keep away from fire or flame. Keep bottle tightly capped when not in use.

ADVERSE REACTIONS

A localized irritant reaction may occur if Systeme Biolage Anti-Dandruff Shampoo is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.

DOSAGE AND ADMINISTRATION

Prior to applying Systeme Biolage Anti-Dandruff Shampoo, soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth, or emery board. Dry wart site thoroughly. Using the brush applicator supplied, apply Systeme Biolage Anti-Dandruff Shampoo twice to entire wart surface, allowing the first application to dry before applying the second. Continue treatment once or twice a day as directed by physician. Be careful not to apply to surrounding skin.

Clinically visible improvement will normally occur during the first or second week of therapy. Maximum resolution may be expected after four to six weeks of Systeme Biolage Anti-Dandruff Shampoo use.

HOW SUPPLIED

Systeme Biolage Anti-Dandruff Shampoo is supplied in 10ml amber bottles with a brush applicator (NDC 42783-312-10).

Store at controlled room temperature, 15° to 30°C (59° to 86°F).

Manufactured for:

Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent Pending

Revised 06/2011

221619

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Systeme Biolage Anti-Dandruff Shampoo film-forming liquid
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Topical (Advanced Reading)

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Systeme Biolage Anti-Dandruff Shampoo (FDA)
Systeme Biolage Anti-Dandruff Shampoo (AHFS Monograph)

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Warts

Systeme Biolage Anti-Dandruff Shampoo interactions

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Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Systeme Biolage Anti-Dandruff Shampoo or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of Systeme Biolage Anti-Dandruff Shampoo through the skin. Also, young children may be more likely to get skin irritation from Systeme Biolage Anti-Dandruff Shampoo. Systeme Biolage Anti-Dandruff Shampoo should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Systeme Biolage Anti-Dandruff Shampoo should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with Systeme Biolage Anti-Dandruff Shampoo.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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References

FDA/SPL Indexing Data. "O414PZ4LPZ: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
MeSH. "Antifungal Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Salicylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

Systeme Biolage Anti-Dandruff Shampoo Dosage

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