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  5. Label Information: Emoninail Antifungal

FDA Label for Emoninail Antifungal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF,
    7. KEEP OUT OF REACH OF CHILDREN.
    8. WHEN USING THIS PRODUCT,
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABELING:

Emoninail Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Pure Source, Llc. 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 10.00%


Purpose



Topical Antifungal


Uses



Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).


Warnings



  • For external use only

Do Not Use



  • on children under 2 years of age, unless directed by a doctor.

Stop Use And Ask A Doctor If,



  • If irritation occurs or if there is no improvement within 4 weeks.

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


When Using This Product,



avoid contact with eyes.


Directions



  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) 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 change shoes andsocks 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



  • Protect the product in this container from excessive heat and direct sun.

    • Store between 20° to 30°C (68° to 86°F)


Inactive Ingredients



Aqua (Deionized Water), SD-Alcohol 40B, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Alcohol, Polysorbate-20, Polycrylamide, C13-C14 Isoparaffin, Laureth-7, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Ethylhexyglycerin.


Package Labeling:



Label - Label

Label - Label


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