Brevoxyl Gel (Benzoyl Peroxide) - Indications and Dosage

INDICATIONS AND USAGE

Brevoxyl-4 Gel and Brevoxyl-8 Gel are indicated for use in the topical treatment of mild to moderate acne vulgaris. Brevoxyl-4 Gel or Brevoxyl-8 Gel may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

DOSAGE AND ADMINISTRATION

Therapy may be initiated with either Brevoxyl-4 Gel or Brevoxyl-8 Gel. The medication should be applied once or twice daily to affected areas. Frequency of use should be adjusted to obtain the desired clinical response. Gentle cleansing of the affected areas prior to application of Brevoxyl-4 or Brevoxyl-8 may be beneficial. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

HOW SUPPLIED

Brevoxyl-4 Gel and Brevoxyl-8 Gel are supplied in 42.5 g (1.5 oz) and 90 g (3.1 oz) tubes.

Brevoxyl-4 Gel

42.5 g tube NDC 0145-2374-06

90 g tube NDC 0145-2374-08

Brevoxyl-8 Gel

42.5 g tube NDC 0145-2384-06

90 g tube NDC 0145-2384-08

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

U.S. Patent Nos. 4,923,900, 5,086,075