SPL v1
SPL
SPL Set ID 47c37468-ba5c-0d11-e063-6294a90ac554
Route
TOPICAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Apis Mellifera Venom Garlic Tea Tree Oil Angelica Acutiloba Root Allantoin Water Lonicera Japonica Flower Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-13

Description

Undecylenic Acid 25% W/W Bee Venom 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25% W/W Bee Venom 2%

Uses

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

Section 51945-4

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、

Directions

Soak the affected nail inwarm water

to soften it. Gently file the nail to

thin it and remove dirt, being cau-

tious not to harm the nail bed.

Application: Apply full layers of

the solution with the brush onto

affected areas on, around, and

under the nails.a light tingle or burn

is normal for the first 10 minutes

until absorbed.

Frequency: Use twice daily

(morningand night). Visible results

may appear in 6 weeks. Continue

regular use to prevent regrowth.

Do Not Use

• If you are pregnant or breastfeeding

• your skin is injured or cracked.

• you are under 12 years of age.

• irritation or discomfort occurs.

• you are using other medicines on your nails.

Active Ingredients

Undecylenic Acid 25% W/W

Bee Venom 2%

Inactive Ingredients

Water,Lonicerae Japonicae flos,Angelicae,Glycerin, Allantoin, Garlic Extract, Tea Tree Oil.

When Using This Product

• 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.

Stop Use and Ask A Doctor If

if irritation or symptoms worsen

or last for more than 4 weeks.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Antifungal

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、

Directions

Soak the affected nail inwarm water

to soften it. Gently file the nail to

thin it and remove dirt, being cau-

tious not to harm the nail bed.

Application: Apply full layers of

the solution with the brush onto

affected areas on, around, and

under the nails.a light tingle or burn

is normal for the first 10 minutes

until absorbed.

Frequency: Use twice daily

(morningand night). Visible results

may appear in 6 weeks. Continue

regular use to prevent regrowth.

Do Not Use (Do not use)

• If you are pregnant or breastfeeding

• your skin is injured or cracked.

• you are under 12 years of age.

• irritation or discomfort occurs.

• you are using other medicines on your nails.

Active Ingredients (Active ingredients)

Undecylenic Acid 25% W/W

Bee Venom 2%

Inactive Ingredients (Inactive ingredients)

Water,Lonicerae Japonicae flos,Angelicae,Glycerin, Allantoin, Garlic Extract, Tea Tree Oil.

When Using This Product (When using this product)

• 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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

if irritation or symptoms worsen

or last for more than 4 weeks.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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