85966-007 Tea Tree Oil Antifungal Foot Cream

85966-007 Tea Tree Oil Antifungal Foot Cream
SPL v1
SPL
SPL Set ID 3fe8fc55-bd64-a4a8-e063-6294a90ad18c
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (20 g)
Inactive Ingredients
Urea Squalane 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 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-29

Description

ZINC UNDECYLENATE 20% UNDECYLENIC ACID 5%


Medication Information

Warnings and Precautions

For external use only.

Indications and 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.

Dosage and 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.

Description

ZINC UNDECYLENATE 20% UNDECYLENIC ACID 5%

Section 50565-1

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

Section 50566-9

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

Section 50567-7



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.

Section 50570-1



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.

Section 51727-6

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

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

ZINC UNDECYLENATE 20%

UNDECYLENIC ACID 5%


Structured Label Content

Indications and Usage (34067-9)



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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)



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.

Section 50570-1 (50570-1)



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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

ZINC UNDECYLENATE 20%

UNDECYLENIC ACID 5%


Advanced Ingredient Data


Raw Label Data

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