Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Encube Ethicals Private Limited
915834105
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
11822-0350Application Number
M005Marketing Category
OTC Monograph Drug (C200263)Route of Administration
TOPICALEffective Date
March 31, 2025WATERInactive
Code: 059QF0KO0RClass: IACT
ClotrimazoleActive
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