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FDA Product

Flurandrenolide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Flurandrenolide

45802-928

Regulatory Information

45802-928

ANDA207133

C73584

October 11, 2022

USA

Flurandrenolide Lotion USP, 0.05%

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

600093611

Active Ingredients

FLURANDRENOLIDE

Quantity: 0.5 mg in 1 mL

Code: 8EUL29XUQT

Class Code: ACTIB

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

CETYL ALCOHOL

Code: 936JST6JCN

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

MINERAL OIL

Code: T5L8T28FGP

Class Code: IACT

MENTHOL, UNSPECIFIED FORM

Code: L7T10EIP3A

Class Code: IACT

POLYOXYL 40 STEARATE

Code: 13A4J4NH9I

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

FLURANDRENOLIDE

Code: 8EUL29XUQT

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