Akne-mycin Ointment

Generic Name: erythromycin
Dosage Form: ointment

Akne-mycin®
(Erythromycin)

Rx ONLY

2% TOPICAL OINTMENT
FOR ACNE

FOR EXTERNAL USE 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.

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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).

Marketed by:

CORIA LABORATORIES, LTD.
Fort Worth, Texas 76107
Reorder No. 13548-030-25

Manufactured by:
DPT Laboratories Ltd.
San Antonio, TX 78215
128312-1105

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 LABEL 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  
Packaging
# Item Code Package Description
1 NDC:13548-030-25 25 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050584 01/10/1985
Labeler - CORIA LABORATORIES (010977972)
Establishment
Name Address ID/FEI Operations
DPT Laboratories Ltd. 832224526 MANUFACTURE(13548-030)
Revised: 02/2014
 
CORIA LABORATORIES
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