85587-005

85587-005
SPL v1
SPL
SPL Set ID 3b0d79ad-7d84-5f69-e063-6294a90a5a36
Route
TOPICAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (10 g)
Inactive Ingredients
Urea Panthenol Aloe Vera Leaf Juice Ethylhexylglycerin Cocos Nucifera (coconut) Oil Pelargonium Graveolens Leaf Oil Tocopherol Chamomile Citrus Aurantium Dulcis (orange) Peel Oil Origanum Vulgare Leaf Oil Xanthan Gum Nigella Sativa Seed Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Cetyl Alcohol .alpha.-tocopherol Acetate Polysorbate 20 Cucurbita Pepo (pumpkin) Seed Oil Equisetum Arvense Top Eucalyptus Globulus Leaf Oil Water Bisabolol Lavender Oil Sesamum Indicum (sesame) Seed Oil Polysorbate 60 Euphorbia Cerifera (candelilla) Wax Prunus Amygdalus Dulcis (sweet Almond) Oil Hydrogenated Macadamia Seed Oil Safflower Oil Phenoxyethanol Olea Europaea (olive) Fruit Oil Stearic Acid Glyceryl Stearate Se Glycerin Persea Gratissima (avocado) Oil Rosmarinus Officinalis (rosemary) Leaf Oil Curcuma Longa (turmeric) Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-29

Description

Zinc Undecylenate 10%

Purpose

Treats athlete’s foot, Jock itch and worm, Relieves itching, burning, cracking and scaling which accompany these conditions.


Medication Information

Purpose

Treats athlete’s foot, Jock itch and worm, Relieves itching, burning, cracking and scaling which accompany these conditions.

Description

Zinc Undecylenate 10%

Use

Apply a small amount to healthy skin and wait 24 hours to check for irritation

Stop Use

Discontinue if irritation occurs

Warnings

Always perform a 24-hour patch test prior to use; discontinue if irritation occurs, avoid application on broken skin or if allergic to nuts, seeds, or essential oils (e.g., almond, tea tree, lavender), and consult a healthcare provider before use during pregnancy, breastfeeding, or for children under 12.

Questions

https://drhelexin.com

Email: [email protected]

Ask Doctor

Consult a healthcare provider before use during pregnancy, breastfeeding, or for children under 12.

Directions

Gently apply a thin layer to the affected area twice daily (morning and night).

Do Not Use

Avoid application on broken skin or if allergic to nuts, seeds, or essential oils

When Using

Wash the affected area with soap and water, then dry thoroughly.

Active Ingredient

Zinc Undecylenate 10%

Inactive Ingredients

Water,Safflower (Carthamus tinctorius) Seed Oil, Tea Tree (Melaleuca alternifolia) Leaf Oil, Stearic Acid, Cetyl Alcohol, SE - Glyceryl Stearate SE, Tocopheryl Acetate, Glyceryl Stearate, 60 - Polysorbate 60, Glycerin, Urea, Panthenol, Sweet Almond (Prunus dulcis) Oil, Sesame (Sesamum indicum) Seed Oil, Avocado (Persea americana) Oil, Horsetail (Equisetum arvense) Extract, Chamomile (Matricaria chamomilla) Flower Extract, Aloe Barbadensis Leaf Juice, Glyceryl Stearate Citrate, Cetearyl Glucoside, 20 - Polysorbate 20, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Macadamia (Macadamia ternifolia) Seed Oil, Olive (Olea europaea) Fruit Oil, Candelilla (Euphorbia cerifera) Wax, Coconut (Cocos nucifera) Oil, Eucalyptus (Eucalyptus globulus) Leaf Oil, Cetearyl Alcohol*, Geranium (Pelargonium graveolens) Flower Oil, Rice (Oryza sativa) Bran Extract, Sunflower (Helianthus annuus) Extract, Rosemary (Rosmarinus officinalis) Leaf Extract, Tocopherol, Pumpkin (Cucurbita pepo) Seed Oil, Bisabolol, Lavender (Lavandula angustifolia) Flower Oil, Orange (Citrus aurantium dulcis) Peel Oil, Oregano (Origanum vulgare) Leaf Oil, Black Seed (Nigella sativa) Seed Oil, Turmeric (Curcuma longa) Root Extract

Principal Display Panel

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Use

Apply a small amount to healthy skin and wait 24 hours to check for irritation

Purpose

Treats athlete’s foot, Jock itch and worm, Relieves itching, burning, cracking and scaling which accompany these conditions.

Stop Use

Discontinue if irritation occurs

Warnings

Always perform a 24-hour patch test prior to use; discontinue if irritation occurs, avoid application on broken skin or if allergic to nuts, seeds, or essential oils (e.g., almond, tea tree, lavender), and consult a healthcare provider before use during pregnancy, breastfeeding, or for children under 12.

Questions

https://drhelexin.com

Email: [email protected]

Ask Doctor

Consult a healthcare provider before use during pregnancy, breastfeeding, or for children under 12.

Directions

Gently apply a thin layer to the affected area twice daily (morning and night).

Do Not Use (Do not use)

Avoid application on broken skin or if allergic to nuts, seeds, or essential oils

When Using

Wash the affected area with soap and water, then dry thoroughly.

Active Ingredient

Zinc Undecylenate 10%

Inactive Ingredients (Inactive ingredients)

Water,Safflower (Carthamus tinctorius) Seed Oil, Tea Tree (Melaleuca alternifolia) Leaf Oil, Stearic Acid, Cetyl Alcohol, SE - Glyceryl Stearate SE, Tocopheryl Acetate, Glyceryl Stearate, 60 - Polysorbate 60, Glycerin, Urea, Panthenol, Sweet Almond (Prunus dulcis) Oil, Sesame (Sesamum indicum) Seed Oil, Avocado (Persea americana) Oil, Horsetail (Equisetum arvense) Extract, Chamomile (Matricaria chamomilla) Flower Extract, Aloe Barbadensis Leaf Juice, Glyceryl Stearate Citrate, Cetearyl Glucoside, 20 - Polysorbate 20, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Macadamia (Macadamia ternifolia) Seed Oil, Olive (Olea europaea) Fruit Oil, Candelilla (Euphorbia cerifera) Wax, Coconut (Cocos nucifera) Oil, Eucalyptus (Eucalyptus globulus) Leaf Oil, Cetearyl Alcohol*, Geranium (Pelargonium graveolens) Flower Oil, Rice (Oryza sativa) Bran Extract, Sunflower (Helianthus annuus) Extract, Rosemary (Rosmarinus officinalis) Leaf Extract, Tocopherol, Pumpkin (Cucurbita pepo) Seed Oil, Bisabolol, Lavender (Lavandula angustifolia) Flower Oil, Orange (Citrus aurantium dulcis) Peel Oil, Oregano (Origanum vulgare) Leaf Oil, Black Seed (Nigella sativa) Seed Oil, Turmeric (Curcuma longa) Root Extract

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep Out Of Reach Of Children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)