FUNGAL NAIL TREATMENT liquid

FUNGAL NAIL TREATMENT by

Drug Labeling and Warnings

FUNGAL NAIL TREATMENT by is a Otc medication manufactured, distributed, or labeled by Gaoye Marketing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Use

For the effective treatment of nail fungus,discoloration, thickening, splitting,crumbling and brittleness.

Warnings

For external use only.
Do not use

● on children under 2 years of age unless directed by a doctor.
Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.
When using this product

●Possible
side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.
Keep out of reach of children.
If swallowed,get medical help or contacta Poison Control Center right away.

Do not use

on children under 2 years of age unless directed by a doctor.

When Using

When using this product

●Possible
side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.

Stop Use

Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.

Ask Doctor

Stop use and ask a doctor
●if irritation occurs or if there is no improvement within 4 weeks.

Keep Oot Of Reach Of Children

Keep out of reach of children.
If swallowed,get medical help or contacta Poison Control Center right away.

Directions

Directions
1. Apply the product twice a day, in the morning and at night.
2.For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.
3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas.
4. For best results, use this product consistenthy for 3-6 months, as fungal nail infections require prolonged treatment. Visible improvements may appear in as little as 7 days, but complete healing takes longer.

Other information

Preservation method
Store in a cool, shaded place away from direct sunlight. Store at room temperature between15-30°C(59-86°F).

Inactive ingredients

Inactive ingredients
Aloe Vera Extract, Canola Oil, Clove Bud Oil,Lavender Oil, Jojoba Oil, Manuka Oil, Oregano Oil,Peppermint Oil, Propolis Extract, Sweet Almond Oil.Tea Tree Oil, Tocopheryl Acetate.

Questions

Syuekisei@hotmail.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL TREATMENT 
fungal nail treatment liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85308-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
CANOLA OIL (UNII: 331KBJ17RK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CLOVE OIL (UNII: 578389D6D0)
JOJOBA OIL (UNII: 724GKU717M)
MANUKA OIL (UNII: M6QU9ZUH2X)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALMOND OIL (UNII: 66YXD4DKO9)
TEA TREE OIL (UNII: VIF565UC2G)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85308-002-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/03/2025

Labeler - Gaoye Marketing Inc (119447516)

Establishment
Name	Address	ID/FEI	Business Operations
Gaoye Marketing Inc		119447516	manufacture(85308-002)