85150-008

85150-008
SPL v1
SPL
SPL Set ID 34aec10d-a0d0-d956-e063-6394a90a39b2
Route
TOPICAL
Published
Effective Date 2025-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (10 g)
Inactive Ingredients
Peppermint Oil Lavender Oil 2-(2'-hydroxytetracosanoylamino)-octadecane-1,3,4-triol, (2s,3s,4r,2'r)- Apricot Kernel Oil Powdered Cellulose Tea Tree Oil Jojoba Oil Testosterone Bergamot Oil Diethylene Glycol Abietate Tocopherol Camphor Oil Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-09

Description

Undecylenic Acid 10% W/W

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 10% W/W

Use

Effective in getting rid of fungus and promoting healthier nail growth.

Stop Use

if irritation or symptoms worsen or last for more than 4 weeks.

Warnings

• For external use only.

• When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

• Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or symptoms worsen or last for more than 4 weeks.

• Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Ask Doctor

if irritation or symptoms worsen or last for more than 4 weeks.

Directions

• Clean the affected area with soap, soak the nail in warm water to soften it.

• Then let it dry, apply a thin layer of the antifungal solution included in the kit 2-3 times a day.

• Apply the fungus nail patch once a night. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips.

• Keep the patch in this position for 6-8 hours, preferably overnight, and recommended for 3-6 months.

Do Not Use

• If you are pregnant or breastfeeding

• your skin is injured or cracked.

• you are under 18 years of age.

• irritation or discomfort occurs.

• you are using other medicines on your nails.

When Using

• Do not apply to other parts of the body.

• Avoid making eye contact. In case of accidental eye contact, flush eyes with copious amounts of cold tap water.

• This product may not work for everyone.

Active Ingredient

Undecylenic Acid 10% W/W

Other Information

Store at room temperature. Reseal pouch after each use.

Inactive Ingredients

Mineral oil, Apricot Kernel Oil, Tea Tree Oil,Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil, Hydrogel, Elastic fabric, Adhesive, Release paper

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Use

Effective in getting rid of fungus and promoting healthier nail growth.

Purpose

Antifungal

Stop Use

if irritation or symptoms worsen or last for more than 4 weeks.

Warnings

• For external use only.

• When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

• Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or symptoms worsen or last for more than 4 weeks.

• Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Ask Doctor

if irritation or symptoms worsen or last for more than 4 weeks.

Directions

• Clean the affected area with soap, soak the nail in warm water to soften it.

• Then let it dry, apply a thin layer of the antifungal solution included in the kit 2-3 times a day.

• Apply the fungus nail patch once a night. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips.

• Keep the patch in this position for 6-8 hours, preferably overnight, and recommended for 3-6 months.

Do Not Use (Do not use)

• If you are pregnant or breastfeeding

• your skin is injured or cracked.

• you are under 18 years of age.

• irritation or discomfort occurs.

• you are using other medicines on your nails.

When Using

• Do not apply to other parts of the body.

• Avoid making eye contact. In case of accidental eye contact, flush eyes with copious amounts of cold tap water.

• This product may not work for everyone.

Active Ingredient

Undecylenic Acid 10% W/W

Other Information (Other information)

Store at room temperature. Reseal pouch after each use.

Inactive Ingredients (Inactive ingredients)

Mineral oil, Apricot Kernel Oil, Tea Tree Oil,Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil, Hydrogel, Elastic fabric, Adhesive, Release paper

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)