CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65), Betamethasone Dipropionate (UNII: 826Y60901U) (Betamethasone - UNII:9842X06Q6M)

Available from:

Physicians Total Care, Inc.

INN (International Name):

Clotrimazole

Composition:

Clotrimazole 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis ) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported. Clotrimazole and Betamethasone Dipropionate Cream or Lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dip

Product summary:

Clotrimazole and Betamethasone Dipropionate Cream, USP is supplied in 15-gram (NDC 54868-4546-1) and 45-gram (NDC 54868-4546-0) tubes; boxes of one. Clotrimazole and Betamethasone Dipropionate Lotion is supplied in 30-mL bottles (NDC 54868-5232-0); box of one. Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE - CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE - CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE LOTION
PHYSICIANS TOTAL CARE, INC.
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CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION
RX ONLY
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT
RECOMMENDED FOR DIAPER DERMATITIS.
DESCRIPTION
Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain
combinations of clotrimazole,
a synthetic antifungal agent, and betamethasone dipropionate, a
synthetic corticosteroid, for
dermatologic use.
Chemically, clotrimazole is
1-(_o_-chloro-α,α-diphenylbenzyl)imidazole, with the empirical
formula
C
H ClN , a molecular weight of 344.84, and the following structural
formula:
Clotrimazole is an odorless, white crystalline powder, insoluble in
water and soluble in ethanol.
Betamethasone dipropionate has the chemical name
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-
1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C
H FO , a molecular weight
of 504.59, and the following structural formula:
22
17
2
28
37
7
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder, insoluble in
water.
Each gram of Clotrimazole and Betamethasone Dipropionate Cream, USP
contains 10.0 mg
clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP
(equivalent to 0.5 mg betamethasone),
in a hydrophilic cream consisting of ceteareth-30, cetostearyl
alcohol, mineral oil, phosphoric acid,
propylene glycol, purified water, sodium phosphate monobasic, white
petrolatum; benzyl alcohol as
preservative.
Clotrimazole and betamethasone dipropionate cream is smooth, uniform
and white to off-white in color.
Each gram of Clotrimazole and Betamethasone Dipropionate Lotion
contains 10.0 mg clotrimazole, USP
and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg
betam