ANTIFUNGAL

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

Company

DUNS: 047025993

Effective Date

April 28, 2025

Labeling Type

HUMAN OTC DRUG LABEL

Active Ingredients

Clotrimazole(1 g in 100 g)

Products1

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

NDC Product Code

84722-3059

Application Number

M005

Marketing Category

OTC Monograph Drug (C200263)

Route of Administration

TOPICAL

Effective Date

April 28, 2025

Ingredients

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACT

CETETH-20Inactive

Code: I835H2IHHXClass: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVPClass: IACT

CHLOROCRESOLInactive

Code: 36W53O7109Class: IACT

Code: G07GZ97H65Class: ACTIBQuantity: 1 g in 100 g

CETOSTEARYL ALCOHOLInactive

Code: 2DMT128M1SClass: IACT