Undecylenic Acid
FDA Label NDC 55319-055

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc. for the product Undecylenic Acid (NDC 55319-055). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, if pregnant or breastfeeding, do not use, when using this product, use only as directed, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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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)

* Please review the disclaimer below.