Emoninail Antifungal Liquid
FDA Label NDC 76973-071

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gg Healthworks Inc. for the product Emoninail Antifungal (NDC 76973-071). 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, do not use, stop use and ask a doctor if,, keep out of reach of children., when using this product,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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