UNDECYLENIC ACID- 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 the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm)
For relief of:

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

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 warning 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 affected area twice daily (morning and night) or as directed by the 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 the 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 condition persists longer, consult a doctor.
this product is not effective on the scalp or nails

Other information

• store at room temperature 150 - 300C (590 - 860F)
• protect from freezing. if freezing occurs, warm to room temperature.
• keep tightly closed when not in use

Inactive ingredient

isopropyl palmitate

Questions?

Call 1-866-964-0939

Principal Display Panel

FAMILY WELLNESS

MAXIMUM STRENGTH

Anti- Fungal Nail Pen

Undecylenic Acid 25%

Eliminates Fungus on Fingers, Toes and Around Nails

• Pre- fikllled with applicator brush
• Covenient and Easy to use
• Dries Quickly 
• Non - oily, clean Formula

0.05 FL. OZ (1.7 mL)

INGREDIENTS AND APPEARANCE

UNDECYLENIC ACID 
antifungal pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-055
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: 55319-055-17	1.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product	12/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/15/2017

Labeler - Family Dollar Services Inc. (024472631)