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

TEA TREE Oil ANTIFUNGAL Cream by

Drug Labeling and Warnings

TEA TREE Oil ANTIFUNGAL 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 relilef of itching, buring and eracking

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.

STOP USE

Stop use and ask a doctor if . lrritation occurs There is no improvement within 4 weeks.
lf pregnant or breast feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

UREA
WATER
C13-15 ALKANE
MELALEUCA ALTERNIFOLIA LEAF OIL
SQUALANE
GLYCERIN
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 CROSSCOPOLYMER (60000 CP)
ARGININE
CAPRYLYL GLYCOL
MENTHOL
XANTHAN GUM
DISODIUM EDTA
BISABOLOL
SUNFLOWER SEED OIL
BUTYROSPERMUM PARKII (SHEA) BUTTER
CENTELLA ASIATICA EXTRACT
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT
ALOE BARBADENSIS LEAF JUICE
CALENDULA OFFICINALIS EXTRACT
ROSEMARY
LAVENDER OIL
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) FRUIT EXTRACT
MACADAMIA TERNIFOLIA SEED OIL
COCONUT OIL
OLIVE OIL
HELIANTHUS ANNUUS SEED LECITHIN
TOCOPHEROL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEA TREE OIL ANTIFUNGAL CREAM 
zinc undecylenate, undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	0.05 g  in 1 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ORIGANUM VULGARE LEAF OIL (UNII: 7D0CGR40U1)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-15 ALKANE (UNII: 114P5I43UJ)
SQUALANE (UNII: GW89575KF9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
BISABOLOL (UNII: 24WE03BX2T)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
MENTHOL (UNII: L7T10EIP3A)
COCONUT OIL (UNII: Q9L0O73W7L)
SOY SPHINGOLIPIDS (UNII: P491F5HP1U)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
MACADAMIA TERNIFOLIA SEED OIL (UNII: 515610SU8C)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
XANTHAN GUM (UNII: TTV12P4NEE)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PANTHENOL (UNII: WV9CM0O67Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OIL (UNII: M6QU9ZUH2X)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ARGININE (UNII: 94ZLA3W45F)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
UREA (UNII: 8W8T17847W)
ROSEMARY (UNII: IJ67X351P9)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL (UNII: 3Z252A2K9G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-008-01	120 g in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/12/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Meixi Biotechnology Co., Ltd.		625724571	manufacture(85966-008)