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, tri-laureth 4 phosphate, oleyl oleate, trilaneth 4 phosphate, cetostearyl alcohol, sorbitol and fragrance. Akne-mycin marketed in the United States is not of the same composition as Akne-mycin marketed in Europe.

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.

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.

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. NDC 0064-3000-25. Store below 27°C (80°F).

Distributed by:

HEALTHPOINT®

Healthpoint, Ltd.

San Antonio, Texas 78215

1-800-441-8227

Reorder No. 0064-3000-25

127553-1098

Manufactured in:

Republic of Germany

by HERMAL KURT HERRMANN

GmbH & Co

41002708

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

images/pills/p01317d5.jpg