Acne Ointment by GatorFace

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									TOPICAL OINTMENT
FOR ACNE
DESCRIPTION: Akne-mycin (erythromycin)
topical ointment contains erythromycin            PRECAUTIONS: Akne-mycin is for topical
which is produced from a strain of                use only and should be kept out of the
Streptomyces erythraeus. Each gram of             eyes, nose and mouth.
Akne-mycin topical ointment contains 20
mg of erythromycin base in a vehicle              The use of antibiotic agents may be
consisting of mineral oil, petrolatum,            associated with the overgrowth of antibiotic
paraffin, talc, titanium dioxide, trilaureth 4    resistant organisms. If this occurs,
phosphate, oleyl oleate, trilaneth 4              administration of the drug should be
phosphate, cetostearyl alcohol and sorbitol.      discontinued and appropriate measures
Akne-mycin marketed in the United States          taken.
is not of the same composition as Akne-
mycin marketed in Europe.                         ADVERSE REACTIONS: In clinical trials
                                                  there was one report of a possible contact
CLINICAL PHARMACOLOGY: Although                   sensitization which could not be confirmed.
the mechanism by which Akne-mycin acts            There were isolated reports of skin irritation,
in reducing the inflammatory lesions of           such as erythema and peeling.
acne vulgaris is unknown, it is presumably
due to the antibiotic action of the drug.         DOSAGE AND ADMINISTRATION: Akne-
                                                  mycin should be applied to the affected
INDICATIONS AND USAGE: Akne-mycin is              area twice daily, morning and evening.
indicated for topical control of acne vulgaris.
                                                  HOW SUPPLIED: Akne-mycin is supplied
                                                  in a 25 gram sealed tube (NDC# 0064-
CONTRAINDICATIONS: Akne-mycin is                  3000-25).
contraindicated in persons who have shown         Store below 27˚C (80˚F).
hypersensitivity to erythromycin or to any of
the other listed ingredients.                     Rx Only
WARNINGS: The safe use of Akne-mycin              Distributed by:           Manufactured by:
during pregnancy or lactation has not been                              ®
                                                                            DPT Laboratories, Ltd.
established.                                      Healthpoint, Ltd.         San Antonio, Texas 78215
                                                  1-800-441-8227

								
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