CLOTRIMADERM Vaginal cream Ref.[27831] Active ingredients: Clotrimazole

Source: Health Products and Food Branch (CA)  Revision Year: 2020 

Product name

Clotrimaderm Vaginal USP.

Clotrimaderm External Cream.

Summary product information

Route of AdministrationDosage Form/StrengthClinically Relevant Nonmedicinal Ingredients
VaginalCream 1%, 2%For a complete listing see Dosage Forms, Composition and Packaging section.

Dosage forms, composition and packaging

Clotrimaderm Vaginal 6 issupplied in a 50 g tube of 1% vaginal cream in a carton containing 6 disposable plastic applicators and patient instructions. 50 g of Clotrimaderm Vaginal cream 1% issufficient for 6 intravaginal applications with additional cream for extravaginal use if required.

Clotrimaderm Vaginal 3 issupplied in a 25 g tube of 2% vaginal cream in a carton containing 3 disposable plastic applicators and patient instructions. 25 g of Clotrimaderm Vaginal cream 2% issufficient for 3 intravaginal applications with additional cream for extravaginal use if required.

Composition

Clotrimaderm Vaginal 6 contains 10 mg/g of clotrimazole in a cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, 2-octyl dodecanol, purified water, and benzyl alcohol 1% as preservative.

Clotrimaderm Vaginal 3 contains 20 mg/g of clotrimazole in a cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, 2-octyl dodecanol, purified water, and benzyl alcohol 1% as preservative.

Clotrimaderm External Cream 1% contains 10 mg/g of clotrimazole in a cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, 2-octyl dodecanol, purified water, and benzyl alcohol 1% as preservative.

Marketing Informations Authorization Dates
Authorization holder:

Taro Pharmaceuticals Inc., 130 East Drive, Brampton, Ontario, L6T 1C1

Submission control number:

232921

Date of approval:

January 27, 2020

Drugs

Drug Countries
CLOTRIMADERM Canada, Israel

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