85966-008 Tea Tree Oil Antifungal Cream

85966-008 Tea Tree Oil Antifungal Cream
SPL v1
SPL
SPL Set ID 45bd3ad0-a0d1-314f-e063-6394a90a9a3a
Route
TOPICAL
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (0.05 g)
Inactive Ingredients
Water Origanum Vulgare Leaf Oil Glycerin Peg-100 Stearate Simmondsia Chinensis (jojoba) Seed Oil Phenoxyethanol C13-15 Alkane Squalane Edetate Disodium Olive Oil Tocopherol Bisabolol Butyrospermum Parkii (shea) Butter Calendula Officinalis Flower Aloe Vera Leaf Juice Melaleuca Alternifolia (tea Tree) Leaf Oil Menthol Coconut Oil Soy Sphingolipids Centella Asiatica Triterpenoids Macadamia Ternifolia Seed Oil Lecithin, Sunflower Xanthan Gum Sunflower Oil Panthenol Lavender Oil Cetearyl Alcohol Glyceryl Stearate Leptospermum Scoparium Branch/leaf Oil Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Caprylyl Glycol Arginine Matricaria Chamomilla Flowering Top Urea Rosemary Prunus Amygdalus Dulcis (sweet Almond) Seed Meal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-12

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 relilef of itching, buring and eracking

Dosage and 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.

Description

ZINC UNDECYLENATE 20% UNDECYLENIC ACID 5%

Section 50565-1



Keep out of reach of children.

lf swallowed, get medical help or contact a Poison Control Center night away.

Section 50566-9



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.

Section 50567-7



Ask a doctor before use if you have Diabetes.

When using this product ,Avoid contact with the eyes.

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

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

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 relilef of itching, buring and eracking

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 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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)



Keep out of reach of children.

lf swallowed, get medical help or contact a Poison Control Center night away.

Section 50566-9 (50566-9)



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.

Section 50567-7 (50567-7)



Ask a doctor before use if you have Diabetes.

When using this product ,Avoid contact with the eyes.

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

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

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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