Signature Care Athletes Foot Antifungal Liquid
FDA Label NDC 23667-813

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Formulated Solutions, Llc for the product Signature Care Athletes Foot Antifungal (NDC 23667-813). 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, 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 Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlet's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief if itching, burning, cracking

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

Do Not Use

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

When Using This Product

  • avoid contact with the eyes
  • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not punture or incinerate. Do not store at temperature above 120°F (49°C).

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 (1-800-222-1222).

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily
  • use daily for 4 weeks; if condition persist longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

alcohol denat, butylated hydroxytoluene, isobutane, polyethylene glycol 300, polysorbate 20

Questions Or Comments?

1-800-719-9260

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