Akne-mycin

Coria Laboratories

FULL PRESCRIBING INFORMATION: CONTENTS*

• AKNE-MYCIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• AKNE-MYCIN INDICATIONS AND USAGE
• AKNE-MYCIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• AKNE-MYCIN ADVERSE REACTIONS
• AKNE-MYCIN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

FULL PRESCRIBING INFORMATION

Rx ONLY

2% TOPICAL OINTMENT
FOR ACNE

FOR EXTERNAL USE ONLY

AKNE-MYCIN 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.

AKNE-MYCIN INDICATIONS AND USAGE

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

AKNE-MYCIN 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.

AKNE-MYCIN 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 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).

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.