ClindaMax Gel

ClindaMax® Gel (Clindamycin Phosphate Gel), for topical use, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide and purified water.

The structural formula is represented below:

The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-(α)-D-galacto-octopyranoside 2-(dihydrogen phosphate).

ClindaMax® (Clindamycin Phosphate Gel) is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS,WARNINGS and ADVERSE REACTIONS.)

ClindaMax® (Clindamycin Phosphate 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.

Topically applied clindamycin topical solution can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

DOSAGE AND ADMINISTRATION

Apply a thin film of ClindaMax® (Clindamycin Phosphate Gel) twice daily to affected area.

Keep container tightly closed.

ClindaMax® Gel (Clindamycin Phosphate Gel USP, 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

30 gram tube NDC 0462-0390-30                     60 gram tube NDC 0462-0390-60

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

January 2008

PharmaDerm®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com

I8390C
R1/08

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G LABEL

NDC 0462-0390-30

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%)
equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only
30 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON

NDC 0462-0390-30

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%) equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only

30 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G LABEL

NDC 0462-0390-60

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%)
equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only
60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON

NDC 0462-0390-60

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%) equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only
60 g