Sally Hansen
FDA Label NDC 66184-151

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coty Us Llc for the product Sally Hansen (NDC 66184-151). 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, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

cures most ringworm (tinea corporis) and athlete's foot (tinea pedis).

Soothes:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort
  • itchy, scaling skin between the toes
  • itching, burning feet

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with eyes.

Stop use and ask a doctor if:

  • irritation occurs
  • there is not improvement within 4 weeks.

Keep Out Of Reach Of Children.

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

Directions

Use daily for 4 weeks. This product is not effective on the scalp or nails.

  • 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, veniltated shoes
    • change shoes and socks at least once daily

Other Information

  • do not use if the printed seal is broken or missing prior to opening
  • keep away from direct sunlight

Inactive Ingredients

proplylene glycol dicaprylate/dicaprate, parfum/fragrance, limonene, linalool

Questions Or Comments?

To report a serious adverse event and for informaiton or comments on this product call us at 1-800-953-5080

9:00AM-5:00PM EST or visit www.sallyhansen.com

* Please review the disclaimer below.