Elon Dual Defense Anti Fungal Formula Liquid
FDA Label NDC 71171-778

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Little Giant Holdings Llc for the product Elon Dual Defense Anti Fungal Formula (NDC 71171-778). 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 ingredients:, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if:, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Undecylenic Acid 25.0%

Purpose

Antifungal

Uses

Proven clinically effective in the treatment of most athletes's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use.

For effective relief of:

Itching Burning Cracking

Warnings

For external use only.

Do Not Use

on children under 2 years of age except under the supervision of a doctor.

When Using This Product

avoid contact with the eyes.

Stop Use And Ask A Doctor If:

Irritation occurs 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.

Directions

  • Wash affected area well, and let product sit for 1-2 minutes before rinsing.
  • Make sure to dry affected area thoroughly.
  • Supervise children in the use of this product
  • For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at leat once daily
  • Use 1-2 times daily.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor
  • This product is not effective on the scalp or nails

Inactive Ingredients:

Aqua (Deionized Water), Calendula Officianalis Extract, Citrus Grandis (Grapefruit) Seed Extract, Ethyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil.

Other Information

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

Package Labeling:

Elon (Elon)

Elon (Elon)

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