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FDA Approval

Foot Care Clotrimazole

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Rite Aid Corporation
DUNS: 014578892
Effective Date
March 31, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Clotrimazole(10 mg in 1 g)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Foot Care Clotrimazole

Product Details

NDC Product Code
11822-0350
Application Number
M005
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
March 31, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: G07GZ97H65Class: ACTIBQuantity: 10 mg in 1 g
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GUClass: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: KH7I04HPUUClass: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58XClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
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