85587-001

85587-001
SPL v1
SPL
SPL Set ID 337ecbf5-0b07-98d5-e063-6294a90afc8d
Route
TOPICAL
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (10 g)
Inactive Ingredients
Bisabolol Lavender Oil Aloe Barbadensis Leaf Juice Curcuma Longa (turmeric) Root Stearic Acid Polysorbate 60 Olea Europaea (olive) Fruit Oil Euphorbia Cerifera (candelilla) Wax Melaleuca Alternifolia (tea Tree) Leaf Oil .alpha.-tocopherol Acetate Xanthan Gum Phenoxyethanol Cocos Nucifera (coconut) Oil Eucalyptus Globulus Leaf Oil Pumpkin Seed Oil Citrus Aurantium Dulcis (orange) Peel Oil Commiphora Africana Resin Hydrogenated Macadamia Seed Oil Geranium Oil, Algerian Type Carthamus Tinctorius (safflower) Seed Oil Cetyl Alcohol Glyceryl Stearate Se Glycerin Urea Sesamum Indicum (sesame) Seed Oil Equisetum Arvense Top Ethylhexylglycerin Rosmarinus Officinalis (rosemary) Leaf Oil Tocopherol Pomegranate Polysorbate 20 Chamomile Oregano Leaf Oil Water Almond Oil Persea Gratissima (avocado) Oil Panthenol Nigella Sativa Seed Oil Piper Methysticum Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-24

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://neatiquebeauty.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%

Other Information

Store between 68°F - 77°F (20°C - 25°C)

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, Kava Kava (Piper methysticum) Root Extract, Turmeric (Curcuma longa) Root Extract, Myrrh (Commiphora myrrha) Resin Extract, Pomegranate (Punica granatum) Fruit Ferment Filtrate

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://neatiquebeauty.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%

Other Information (Other information)

Store between 68°F - 77°F (20°C - 25°C)

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, Kava Kava (Piper methysticum) Root Extract, Turmeric (Curcuma longa) Root Extract, Myrrh (Commiphora myrrha) Resin Extract, Pomegranate (Punica granatum) Fruit Ferment Filtrate

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

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