Tea Tree Oil Antifungal Foot Cream — v1

Tea Tree Oil Antifungal Foot Cream

4 Views

Version

v1

Effective date

September 28, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
3fe8fc55-bd65-a4a8-e063-6294a90ad18c
Set ID
3fe8fc55-bd64-a4a8-e063-6294a90ad18c
Application numbers
M005
Product NDCs
85966-007
Package NDCs
85966-007-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Tea Tree Oil Antifungal Foot Cream
Generic names
ZINC UNDECYLENATE, UNDECYLENIC ACID
Manufacturer names
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
UNDECYLENIC ACID, ZINC UNDECYLENATE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
388VZ25DUR, K3D86KJ24N
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

ZINC UNDECYLENATE 20% UNDECYLENIC ACID 5%
Do Not Use (1)

Sequence 1

Do not use if seal under cap is broken or missing. Close the lid tightly after use. Do not use this product if you are allergic to any of its ingredients. Do not use on children under 2 years of age unless directed by a doctor.
Dosage And Administration (1)

Sequence 1

Test a small area on your skin to check for any potential allergic reaction. . Clean affected area with soap and water anddry thoroughly, · Apply a thin layer over affected area twice daily (morning and night). . Use daily for 4 weeks. if conditionoersists longer, consult a doctor. . For athlete's foot, pay special attention to spaces between the toes, . To preventathlete's foot, apply once or twice daily (morning and/or night). ’ Supervise children in the use of this product, . Thisproduct is not effective on the scalp or nails.
Inactive Ingredient (1)

Sequence 1

UREA WATER C13-15 ALKANE MELALEUCA ALTERNIFOLIA LEAF OIL SQUALANE GLYCERIN CetearyAlcohol/CETEARYL ALCOHOL GLYCEROL STEARATE PEG-100 STEARATE PANTHENOL SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL LEPTOSPERMUM SCOPARIUM OIL CERAMIDE COMPLEX CLR K PHENOXYETHANOL ORIGANUM VULGARE HIRTUM LEAF OIL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER ARGININE CAPRYLYL GLYCOL MENTHOL XANTHAN GUM DISODIUM EDTA
Indications And Usage (1)

Sequence 1

Proven effective in the treatment of most athlete's foot (tinea pedis) . Helps prevent most athlete's foot with daily use For effective relief of itching, burning and cracking.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

label
Purpose (1)

Sequence 1

Antifungal
Spl Product Data Elements (1)

Sequence 1

Tea Tree Oil Antifungal Foot Cream ZINC UNDECYLENATE, UNDECYLENIC ACID UREA SQUALANE ZINC UNDECYLENATE UNDECYLENIC ACID GLYCERIN GLYCERYL STEARATE PEG-100 STEARATE C13-15 ALKANE WATER MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL PANTHENOL LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OIL UNDECYLENIC ACID UNDECYLENIC ACID SOY SPHINGOLIPIDS PHENOXYETHANOL EDETATE DISODIUM ORIGANUM VULGARE LEAF OIL CETEARYL ALCOHOL ARGININE CAPRYLYL GLYCOL MENTHOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) XANTHAN GUM
Stop Use (1)

Sequence 1

Stop use and ask a doctor if , lrritation occurs There is no improvement within 4 weeks.
Warnings (1)

Sequence 1

For external use only.
When Using (1)

Sequence 1

Ask a doctor before use if you have .Diabetes. When using this product . Avoid contact with the eyes. If pregnant or breast-feeding, ask a health professional before use.

OpenFDA raw payload

{'application_number': ['M005'],
 'brand_name': ['Tea Tree Oil Antifungal Foot Cream'],
 'generic_name': ['ZINC UNDECYLENATE, UNDECYLENIC ACID'],
 'is_original_packager': [True],
 'manufacturer_name': ['GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD'],
 'package_ndc': ['85966-007-01'],
 'product_ndc': ['85966-007'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3fe8fc55-bd65-a4a8-e063-6294a90ad18c'],
 'spl_set_id': ['3fe8fc55-bd64-a4a8-e063-6294a90ad18c'],
 'substance_name': ['UNDECYLENIC ACID', 'ZINC UNDECYLENATE'],
 'unii': ['K3D86KJ24N', '388VZ25DUR']}