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Benzamycin

Indications & Dosage
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INDICATIONS

BENZAMYCIN Topical Gel is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION

BENZAMYCIN 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

Compounding Directions

Size
(Net Weight)
NDC 0066- Benzoyl Peroxide Gel Active Erythromycin Powder
(In Plastic Vial)
Ethyl Alcohol (70%) To Be Added
23.3 grams
(as dispensed)
0510-23 20 grams 0.8 grams 3 mL
46.6 grams
(as dispensed)
0510-46 40 grams 1.6 grams 6 mL

Prior to dispensing, tap vial until powder flows freely. Add indicated amount of ethyl alcohol (70%) 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). BENZAMYCIN 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.

Prescribing Information as of January 2003. Manufactured for Dermik Laboratories, A Division of Aventis Pharmaceuticals Inc. Berwyn, PA 19312, USA. by Aventis Pharmaceuticals Puerto Rico Inc. Manati, Puerto Rico 00674. FDA Rev date: 1/27/2003

Brand Name: Benzamycin
Generic Name: Erythromycin

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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