76986-007

76986-007
SPL v1
SPL
SPL Set ID 37332cdf-7171-42cc-e063-6394a90a0fcf
Route
TOPICAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (11 g)
Inactive Ingredients
Alcohol Hydroxypropylcellulose Zanthoxylum Bungeanum Fruit Glycolic Acid Propylene Glycol Salicylic Acid Edetate Disodium Water Urea Menthol Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-10

Description

Undecylenic Acid 11%

Purpose

For Healthier and Stronger Nails.


Medication Information

Purpose

For Healthier and Stronger Nails.

Description

Undecylenic Acid 11%

Use

For superficial skin fungal infections, skin candidiasis, onychomycosis.

Stop Use

Stop Using and ask a doctor if irritation or redness develops and lasts.

Warnings

.For external use only.

.Contraindicated for children, pregnant and lactating women.

.Prohibited for those who are allergic to this product. Allergic persons should be cautious.

.Prohibit the use of this product when the properties of the product have changed.

Ask Doctor

In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

For external use only. Use the brush to apply a layer ofliquid directly to the affected nail(s),2-3 times dailyfor 2-4 weeks.

Do Not Use

Do not use if there is any burning sensation, redness or swelling at the site of application.

When Using

When Using this product, avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

Undecylenic Acid 11%

Other Information

· If you are using other drugs, please consult your physician or pharmacist before using this product.

· Shielded from light, sealed, stored in a cool place (not more than 20°C).

Inactive Ingredients

Alcohol, Water, Urea, Propylene Glycol, Salicylic Acid, Menthylum, Hydroxypropylcellulose, Zanthoxylum Bungeanum Fruit

Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Glycolic Acid

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of Children.


Structured Label Content

Use

For superficial skin fungal infections, skin candidiasis, onychomycosis.

Purpose

For Healthier and Stronger Nails.

Stop Use

Stop Using and ask a doctor if irritation or redness develops and lasts.

Warnings

.For external use only.

.Contraindicated for children, pregnant and lactating women.

.Prohibited for those who are allergic to this product. Allergic persons should be cautious.

.Prohibit the use of this product when the properties of the product have changed.

Ask Doctor

In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

For external use only. Use the brush to apply a layer ofliquid directly to the affected nail(s),2-3 times dailyfor 2-4 weeks.

Do Not Use (Do not use)

Do not use if there is any burning sensation, redness or swelling at the site of application.

When Using

When Using this product, avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

Undecylenic Acid 11%

Other Information (Other information)

· If you are using other drugs, please consult your physician or pharmacist before using this product.

· Shielded from light, sealed, stored in a cool place (not more than 20°C).

Inactive Ingredients (Inactive ingredients)

Alcohol, Water, Urea, Propylene Glycol, Salicylic Acid, Menthylum, Hydroxypropylcellulose, Zanthoxylum Bungeanum Fruit

Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Glycolic Acid

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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