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  5. Label Information: Undecylenic Acid

FDA Label for Undecylenic Acid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. IF PREGNANT OR BREASTFEEDING
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. USE ONLY AS DIRECTED
    9. STOP USE AND CONSULT A DOCTOR IF
    10. KEEP OUT OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENT
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL

Undecylenic Acid Product Label

The following document was submitted to the FDA by the labeler of this product Family Dollar Services Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.