Erythromycin-Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris.
DOSAGE AND ADMINISTRATION
Erythromycin-Benzoyl Peroxide Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.
How Supplied and Compounding Directions:
Size (Net Weight)
NDC 45802-083-
Benzoyl Peroxide Gel
Active Erythromycin Powder (In Plastic Vial)
70% Ethyl Alcohol To Be Added
23.3 grams (as dispensed)
02
20 grams
0.8 grams
3 mL
46.6 grams (as dispensed)
86
40 grams
1.6 grams
6 mL
Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin. Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). Erythromycin-Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label.
NOTE: Prior to reconstitution, store at room temperature between 15° and 30°C (59° – 86°F).
After reconstitution, store under refrigeration between 2° and 8°C (36° – 46°F).
Do not freeze. Keep tightly closed. Keep out of the reach of children.
Rx Only
Manufactured by: Valeant Pharmaceuticals International Inc. Laval, Quebec, Canada H7L 4A8