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, trilaneth 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
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
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-
Store below 27˚C (80˚F).
DPT Laboratories, Ltd.
San Antonio, Texas 78215