TEA TREE OIL ANTIFUNGAL FOOT CREAM- zinc undecylenate, undecylenic acid cream

Tea Tree Oil Antifungal Foot Cream by

Drug Labeling and Warnings

Tea Tree Oil Antifungal Foot Cream by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD, Guangzhou Meixi Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC UNDECYLENATE 20%
UNDECYLENIC ACID 5%

PURPOSE

Antifungal

INDICATIONS & USAGE

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

For external use only.

DO NOT USE

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.

WHEN USING

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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEA TREE OIL ANTIFUNGAL FOOT CREAM 
zinc undecylenate, undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	20 g  in 100 g
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
UREA (UNII: 8W8T17847W)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-15 ALKANE (UNII: 114P5I43UJ)
WATER (UNII: 059QF0KO0R)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
PANTHENOL (UNII: WV9CM0O67Z)
LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OIL (UNII: M6QU9ZUH2X)
SOY SPHINGOLIPIDS (UNII: P491F5HP1U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ORIGANUM VULGARE LEAF OIL (UNII: 7D0CGR40U1)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ARGININE (UNII: 94ZLA3W45F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MENTHOL (UNII: L7T10EIP3A)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-007-01	1 in 1 BOX	09/29/2025
1		50 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/29/2025

Labeler - GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD (847858432)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Meixi Biotechnology Co., Ltd.		625724571	manufacture(85966-007)