DERMFREE FUNGI NAIL
Approved
Approval ID
33693bba-2dfb-6572-e063-6294a90ac9e0
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
Jiangxi Yudexi Pharmaceutical Co., LTD
DUNS: 455662836
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tolnaftate 1% FUNGI NAIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code85248-004
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate 1% FUNGI NAIL
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (7)
PSEUDOLARIX AMABILIS BARKInactive
Code: 49G13A93VE
Classification: IACT
TOLNAFTATEActive
Quantity: 1 g in 100 mL
Code: 06KB629TKV
Classification: ACTIB
EUPHORBIA HIRTA WHOLEInactive
Code: L13YF113GN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
RESORCINOLInactive
Code: YUL4LO94HK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRACRYLIC ACIDInactive
Code: C4ZF6XLD2X
Classification: IACT