Clotrimazole
Clotrimazole Vaginal Cream, USP
Approved
Approval ID
4aaae616-179b-40f1-8a39-6a1ddd414070
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 29, 2025
Manufacturers
FDA
Cardinal Health (Leader) 70000
DUNS: 063997360
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70000-0729
Application NumberANDA074165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clotrimazole
Product Specifications
Route of AdministrationVAGINAL
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (9)
CLOTRIMAZOLEActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GU
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT