DERMFREE HELPS WITH NAGELPILZ
84010-097
Approved
Approval ID
32c94b5d-b77c-ad01-e063-6394a90a1cba
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 14, 2025
Manufacturers
FDA
Jiangxi Hemei Pharmaceutical Co., Ltd
DUNS: 724892056
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tolnaftate 1% Helps With Nagelpilz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84010-097
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate 1% Helps With Nagelpilz
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (7)
PSEUDOLARIX AMABILIS BARKInactive
Code: 49G13A93VE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRACRYLIC ACIDInactive
Code: C4ZF6XLD2X
Classification: IACT
TOLNAFTATEActive
Quantity: 1 g in 100 mL
Code: 06KB629TKV
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
RESORCINOLInactive
Code: YUL4LO94HK
Classification: IACT
EUPHORBIA HIRTA WHOLEInactive
Code: L13YF113GN
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/15/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/15/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/15/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/15/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/15/2025
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 4/15/2025
OTC - WHEN USING SECTION
LOINC: 50567-7Updated: 4/15/2025
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 4/15/2025
OTC - ASK DOCTOR SECTION
LOINC: 50569-3Updated: 4/15/2025
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 4/15/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/15/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/15/2025