Foot Cure Antifungal Foot Balm
Approved
Approval ID
ac6075bf-cc1d-4e8a-aa13-5a85e80f34ee
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Sansar LLC
DUNS: 127927811
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZINC UNDECYLENATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83691-010
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC UNDECYLENATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (14)
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
ZINC UNDECYLENATEActive
Quantity: 10 g in 100 g
Code: 388VZ25DUR
Classification: ACTIB
SYNTHETIC BEESWAXInactive
Code: 08MNR5YE2R
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
SAFFLOWER OILInactive
Code: 65UEH262IS
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
ROSEMARY OILInactive
Code: 8LGU7VM393
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
MACADAMIA OILInactive
Code: 515610SU8C
Classification: IACT
GERANIUM OIL, ALGERIAN TYPEInactive
Code: 5Q1I94P4WG
Classification: IACT
ALMOND OILInactive
Code: 66YXD4DKO9
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/18/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/18/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/18/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/18/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/18/2025
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 4/18/2025
OTC - WHEN USING SECTION
LOINC: 50567-7Updated: 4/18/2025
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 4/18/2025
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 4/18/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/18/2025