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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 REACH 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 Harmon Store 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 cure of most tinea pedis (athete's foot) and tinea corporis (ringworm)

For relief of:

  • discomforts which may accompany these conditons
  • itching
  • burning
  • redness
  • irritation
  • scaling
  • soreness

Warnings



For external use only.


If Pregnant Or Breastfeeding



consult a healthcare professional before use.


Do Not Use



on children under 2 years of age unless directed by the doctor.


When Using This Product



avoid contact with eyes.


Use Only As Directed



by the 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 Reach 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
  • apply a thin layer of the product over the affected area twice daily (morning and evening) or as directed by a doctor
  • 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 changes shoes and socks atleast 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



Harmon Facevalues

Maximum strength

Anti- Fungal Solution

Undecylenic Acid

Eliminates fungus on fingers, toes, and around nails

  • Easy to apply
  • Dries quickly
  • Non-oily,clear formula
  • Lightly scented

    • 1 FL OZ (30mL)


* Please review the disclaimer below.