MAXXACNE^®-C

COMPOSITION: Each topical gel tube contains:

Clindamycin ……...………………….1% (kl/kl)

Excipients: Carbomer 940, Propylene glycol, Ethanol 96%, Butylated hydroxytoluene, Methylparaben, Propylparaben, Polyoxyl 40 hydrogenated castor oil, Sodium hydroxide, Purified water.

INDICATIONS

MAXXACNE^®-C gel is indicated in the treatment of acne vulgaris

DOSAGE AND ADMINISTRATION

Apply a thin film of clindamycin topical gel twice daily to affected area

CONTRAINDICATIONS

MAXXACNE^®-C gel is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

WARNINGS AND PRECAUTIONS

Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudo-membranous colitis) have been reported with the use of topical clindamycin. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.

In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.

Clindamycin should be prescribed with caution to atopic individuals.

Use in pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women, this drug should be used during pregnancy only if clearly needed.

It is not known whether clindamycin is excreted in human milk following use of clindamycin gel. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

PRESENTATION

Aluminium tube of 15g gel. Box of 1 tube.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and Distributed by: AMPHARCO U.S.A - PJSC

Nhon Trach 3 IP, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203