UNDECYLENIC ACID- antifungal pen liquid 
Family Dollar Services Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antifungal Nail Pen

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

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

0.05 FL. OZ (1.7 mL)

Family Dollar_Family Wellness - Anti-Fungal Nail Solution Pen_53-091FD-01.jpg

UNDECYLENIC ACID 
antifungal pen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) Undecylenic Acid25 mg  in 1.7 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-055-171.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product12/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/15/2017
Labeler - Family Dollar Services Inc. (024472631)

Revised: 12/2017
Document Id: e9cc4be5-2fe6-43b5-894b-f01ce4ff6b04
Set id: 01a3eb23-bea8-474d-aaf8-aabd23574710
Version: 1
Effective Time: 20171215
 
Family Dollar Services Inc.