UNDECYLENIC ACID- antifungal pen liquid

Undecylenic Acid by

Drug Labeling and Warnings

Undecylenic Acid by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Undecylenic acid 25%w/w

Purpose

Antifungal

Uses​

For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).

For relief of:

• itching
• burning
• redness
• irritation
• scaling
• soreness
• discomfort which may accompany these conditions

Warnings

For external use only

If pregnant or breastfeeding

consult a healthcare professional before use.

Do not use

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

When using this product

avoid contact with eyes

Use only as directed

by a doctor on persons with highly sensitive skin.

Stop use and consult a doctor if

• there is no improvement within 4 weeks
• irritation occurs

Keep out of children.

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

Directions​

Read all warnings and directions. Use only as directed.

• clean the affected area and dry thoroughly
• twist pen base with 3 clicks to saturate brush
• apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor
• brush applicator allows for easy application under nails and surrounding cuticle area
• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between toes
• wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor
• this product is not effective on the scalp or nails

​Other information

• store at room temperature 15°-30°C (59° - 86°F)
• protect from freezing. If freezing occurs, warm to room temperature.
• keep tightly closed when not in use

Inactive ingredient

isopropyl palmitate

Questions?

Call 1-248-449-9300

Principal Display Panel

QC

Quality Choice

Maximum Strength

​Antifungal Pen

​Fungus Treatment

​25% Undecylenic Acid​

Eliminates Fungus on Fingers, Toes and Around Nails

Pre-Filled Pen with Brush Applicator

Convenient & Easy to Use

Dries Quickly

Non-Oily, Clear Formula

.05 FL OZ (1.7 mL)

INGREDIENTS AND APPEARANCE

UNDECYLENIC ACID 
antifungal pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-120
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 mg  in 1.7 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-120-17	1.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product	09/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/01/2015

Labeler - Chain Drug Marketing Association (011920774)