UNDECYLENIC ACID- maximum strength antifungal pen liquid

Undecylenic Acid by

Drug Labeling and Warnings

Undecylenic Acid by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active ingredient

Undecylenic acid 25%w/w

​Purpose

Antifungal

Uses

For 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
• the 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 1-866-910-6874

Principal Display Panel

FAMILY WELLNESS

maximum strength

antifungal pen

25% undecylenic acid

eliminates fungus on fingers, toes and around nails

pre-filled applicator pen brush

dries quickly

0.057 FL OZ (1.7mL)

INGREDIENTS AND APPEARANCE

UNDECYLENIC ACID 
maximum strength antifungal pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-176
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: 55319-176-17	1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	02/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/12/2018

Labeler - Family Dollar Services Inc. (024472631)