BEUKOW ANTIFUNGAL PEN- undecylenic acid 25% antifungal pen liquid

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Use

Helps prevent fungal infections, including tinea pedis (toenail onychomycosis). Relieves itching, burning, and cracking. Cures athlete’s foot.

Warnings

For external use only.

Do not use

If pregnant or breastfeeding, consult a healthcare professional before use.
Do not use on children under 2 years of age unless directed by a doctor.

When Using

avoid contact with eyes.
Use only as directed by a doctor on persons with highly sensitive skin.

Stop Use

if there is no improvement within 4 weeks or if irritation occurs.

Ask Doctor

if there is no improvement within 4 weeks or if irritation occurs.

Keep Out Of Reach Of Children

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

Prep: Wash the affected area with soap and water. Soak the nail to soften it.
For toenail fungus:
Gently file thickened areas of the nail every 2-3 days (avoid damaging nail bed).
Apply a thin layer over the entire nail surface, under the nail edge, and around the cuticle.
Use twice daily: morning and evening for at least 6 weeks.
For best results, continue use for 3-6 months or as directed by a doctor.
For athlete’s foot:
Apply to affected areas and between toes.
Allow product to dry fully before putting on socks or shoes.

Other information

Store at room temperature 15°C-30°C (59°F-86°F).
Close cap tightly after each use.
Keep away from direct sunlight and excessive moisture.

Inactive ingredients

Almond Oil, Tea Tree Oil, Mineral Oil, Peppermint Oil, Tocopherol (Vitamin E).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEUKOW ANTIFUNGAL PEN 
undecylenic acid 25% antifungal pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85248-200
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
MINERAL OIL (UNII: T5L8T28FGP)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALMOND OIL (UNII: 66YXD4DKO9)
TEA TREE OIL (UNII: VIF565UC2G)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85248-200-01	4 in 1 BOX	05/06/2026
1		3 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/06/2026

Labeler - Jiangxi Yudexi Pharmaceutical Co., LTD (455662836)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.		411295811	manufacture(85248-200)