SPL v2
SPL
SPL Set ID ac6075bf-cc1d-4e8a-aa13-5a85e80f34ee
Route
TOPICAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (10 g)
Inactive Ingredients
Coconut Oil Synthetic Beeswax Shea Butter Macadamia Oil Alpha-tocopherol Safflower Oil Olive Oil Rosemary Oil Eucalyptus Oil Geranium Oil, Algerian Type Almond Oil Tea Tree Oil Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-30

Description

Zinc Undecylenate 10% 

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Zinc Undecylenate 10% 

Uses

Removes callouses, softens rough areas, deeply moisturizes feet & rehydrates heels. Treats athlete's foot, jock itch, eczema and ringworm. Relieves itching, burning, cracking and scaling.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Section 50570-1

Do not use in children under 2 years of age unless directed by doctor.

Section 51945-4

Warnings

For External Use only.

Directions 

Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.

Active Ingredient

Zinc Undecylenate 10% 

Inactive Ingredients 

Macadamica Oil, Organic Coconut Oil, Organic Shea Butter, Safflower Seed Oil, Sweet Almond Oil, Beeswax, Olive Oil, Essential Oils (Tea Tree, Eucalyptus, Lavender, Rosemary, Geranium), Tocopherol (Vit-E)

When Using This Product
  • Do not get into eyes 
Stope Use and Ask Doctor If 
  • irritation occurs or allergic reaction

Structured Label Content

Uses

Removes callouses, softens rough areas, deeply moisturizes feet & rehydrates heels. Treats athlete's foot, jock itch, eczema and ringworm. Relieves itching, burning, cracking and scaling.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Section 50570-1 (50570-1)

Do not use in children under 2 years of age unless directed by doctor.

Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

For External Use only.

Directions  (DIRECTIONS )

Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.

Active Ingredient

Zinc Undecylenate 10% 

Inactive Ingredients 

Macadamica Oil, Organic Coconut Oil, Organic Shea Butter, Safflower Seed Oil, Sweet Almond Oil, Beeswax, Olive Oil, Essential Oils (Tea Tree, Eucalyptus, Lavender, Rosemary, Geranium), Tocopherol (Vit-E)

When Using This Product (When using this product)
  • Do not get into eyes 
Stope Use and Ask Doctor If  (Stope use and ask doctor if )
  • irritation occurs or allergic reaction

Advanced Ingredient Data


Raw Label Data

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