Rx Item-Duac Topical 1.2(1)% 5% Gel 45Gm By Glaxosmithkline Rx

DUAC: Package Insert and Label Information
By Stiefel Laboratories Inc | Last revised: 15 April 2015
DUAC- clindamycin phosphate and benzoyl peroxide gel
Stiefel Laboratories Inc

1 INDICATIONS AND USAGE

1.1 Indication
DUAC� (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older.

1.2 Limitations of Use
DUAC Gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

2 DOSAGE AND ADMINISTRATION



Apply a thin layer of DUAC Gel to the face once daily, in the evening or as directed by the physician. The skin should be gently washed, rinsed with warm water, and patted dry before applying DUAC Gel. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin.

DUAC Gel is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Gel, 1.2%/5%

DUAC Gel is a white to slightly yellow, opaque gel. Each gram of DUAC Gel contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide.

4 CONTRAINDICATIONS

4.1 Hypersensitivity
DUAC Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Gel. [See Adverse Reactions (6.2).]

4.2 Colitis/Enteritis
DUAC Gel is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)].

RX ITEM-Duac Topical 1.2(1)% 5% Gel 45Gm
NDC 00145-2371-05 UPC/GTIN No.3-01452-37105-3 Mfg.Part No.237105

Duac Topical 1.2(1)% 5% Gel 45Gm By Glax
BRAND: DUAC NDC: 00145-2371-05,145237105 UPC: 3-01452-37105-3,301452371053 Glaxosmithkline/Rx

CLINDAMYCIN PHOS/BENZOYL
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