FDA.reportPublic FDA data

Tea Tree Oil Antifungal Foot Cream

Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2025-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:06

Label at a glance#

ProductTea Tree Oil Antifungal Foot Cream
Active ingredientZINC UNDECYLENATE, UNDECYLENIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ZINC UNDECYLENATE 20%
UNDECYLENIC ACID 5%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION


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.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION


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.

OTC - WHEN USING SECTION


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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313551undecylenic acid 5 % / zinc undecylenate 20 % Topical CreamPSN1
313551undecylenic acid 50 MG/ML / zinc undecylenate 200 MG/ML Topical CreamSCD1
313551undecylenic acid 5 % / zinc undecylenate 20 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-007-01Tea Tree Oil Antifungal Foot Cream50 g in 1 BOTTLECREAM501
85966-007-01Tea Tree Oil Antifungal Foot Cream1 in 1 BOXCREAM11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85966-00785966-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WIACT
SQUALANEGW89575KF9IACT
ZINC UNDECYLENATE388VZ25DURACTIB
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
C13-15 ALKANE114P5I43UJIACT
WATER059QF0KO0RIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
PANTHENOLWV9CM0O67ZIACT
LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OILM6QU9ZUH2XIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
SOY SPHINGOLIPIDSP491F5HP1UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM7FLD91C86KIACT
ORIGANUM VULGARE LEAF OIL7D0CGR40U1IACT
CETEARYL ALCOHOL2DMT128M1SIACT
ARGININE94ZLA3W45FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MENTHOLL7T10EIP3AIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tea Tree Oil Antifungal Foot CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe8fc55-bd64-a4a8-e063-6294a90ad18c2025-09-28WarningsExact identifier
ndc (package): 85966-007-01
ndc (product): 85966-007
ndc11 (package): 85966000701
spl id: 3fe8fc55-bd65-a4a8-e063-6294a90ad18c
spl set id: 3fe8fc55-bd64-a4a8-e063-6294a90ad18c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.