Akne-mycin Ointment

erythromycin

Dosage Form: ointment
Akne-mycin®

(Erythromycin)

2% TOPICAL OINTMENT

FOR ACNE

FOR EXTERNAL USE ONLY

Rx ONLY

Akne-mycin Ointment Description

Akne-mycin (erythromycin) topical ointment contains erythromycin which is produced from a strain of Streptomyces erythraeus. Each gram of Akne-mycin topical ointment contains 20 mg of erythromycin base in a vehicle consisting of mineral oil, petrolatum, paraffin, talc, titanium dioxide, trilaureth 4 phosphate, oleyl oleate, tricetareth 4 phosphate, cetostearyl alcohol and sorbitol. Akne-mycin marketed in the United States is not of the same composition as Akne-mycin marketed in Europe.

Akne-mycin Ointment - Clinical Pharmacology

Although the mechanism by which Akne-mycin acts in reducing the inflammatory lesions of acne vulgaris is unknown, it is presumably due to the antibiotic action of the drug.

Indications and Usage for Akne-mycin Ointment

Akne-mycin is indicated for topical control of acne vulgaris.

Contraindications

Akne-mycin is contraindicated in persons who have shown hypersensitivity to erythromycin or to any of the other listed ingredients.

Warnings

The safe use of Akne-mycin during pregnancy or lactation has not been established.

Precautions

Akne-mycin is for topical use only and should be kept out of the eyes, nose and mouth.

The use of antibiotic agents may be associated with the overgrowth of antibiotic resistant organisms. If this occurs, administration of the drug should be discontinued and appropriate measures taken.

Adverse Reactions

In clinical trials there was one report of a possible contact sensitization which could not be confirmed. There were isolated reports of skin irritation, such as erythema and peeling.

Akne-mycin Ointment Dosage and Administration

Akne-mycin should be applied to the affected area twice daily, morning and evening.

How is Akne-mycin Ointment Supplied

Akne-mycin is supplied in a 25 gram sealed tube. Store below 27°C (80°F).

Distributed by:

CORIA LABORATORIES,

a division of Valeant

Pharmaceuticals North America

Fort Worth, TX 76107

1-800-321-4576

www.CoriaLabs.com

Manufactured by:

DPT Laboratories Ltd.

San Antonio, TX 78215

129177-0610

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

Akne-mycin®2%

(Erythromycin)

NDC 13548-030-25

Rx ONLY

FOR EXTERNAL USE ONLY

TOPICAL OINTMENT

FOR ACNE

NET WT 25 g

CORIA®

LABORATORIES, LTD.

AKNE-MYCIN  erythromycin  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13548-030 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength erythromycin (erythromycin) erythromycin 20 mg  in 1 g

Inactive Ingredients Ingredient Name Strength mineral oil   petrolatum   paraffin   talc   titanium dioxide   oleyl oleate   cetostearyl alcohol   sorbitol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 13548-030-25 25 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050584	01/10/1985

Labeler - CORIA LABORATORIES (010977972)

Registrant - Valeant Pharmaceuticals North America (831922468)

Establishment
Name	Address	ID/FEI	Operations
DPT Laboratories Ltd.		832224526	MANUFACTURE

Revised: 06/2010CORIA LABORATORIES

More Akne-mycin Ointment resources

• Akne-mycin Ointment Side Effects (in more detail)
• Akne-mycin Ointment Use in Pregnancy & Breastfeeding
• Akne-mycin Ointment Support Group
• 0 Reviews for Akne-mycin - Add your own review/rating

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