FDA Product

Tolnafate

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

Basic Information

Product Name

Tolnafate

FDA Product Code

83324-234

Regulatory Information

NDC Product Code

83324-234

Application Number

M005

Marketing Category

C200263

Effective Date

May 1, 2025

Territorial Authority

USA

FDA Title

Quality Choice Tolnaftate Powder Spray Talc-Free

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

1

Company Information

ManufacturerChain Drug Marketing Association

DUNS Number

011920774

Active Ingredients

BHT

Code: 1P9D0Z171K

Class Code: IACT

PPG-12-BUTETH-16

Code: 58CG7042J1

Class Code: IACT

ISOBUTANE

Code: BXR49TP611

Class Code: IACT

KAOLIN

Code: 24H4NWX5CO

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

ZEA MAYS (CORN) STARCH

Code: O8232NY3SJ

Class Code: IACT

Quantity: 10 mg in 1 g

Code: 06KB629TKV

Class Code: ACTIB

Active Moieties

TOLNAFTATE

Code: 06KB629TKV

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