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Name:Akne-mycin
Manufacturer:Coria Laboratories
Category:Prescription Marketed Drugs


Akne-mycin® (Erythromycin)

AKNE-MYCIN - erythromycin ointment 
CORIA LABORATORIES

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Akne-mycin®
(Erythromycin)

2% TOPICAL OINTMENT
FOR ACNE

FOR EXTERNAL USE ONLY

Rx ONLY

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.

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

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.

DOSAGE AND ADMINISTRATION

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

HOW 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.

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

AKNE-MYCIN 
erythromycin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC: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: 06/2010 CORIA LABORATORIES



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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