Family Wellness Antifungal
FDA Label NDC 55319-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar for the product Family Wellness Antifungal (NDC 55319-300). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                            Purpose

Tolnaftate 1%................................................ Antifungal

Otc - Purpose

Uses

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

Warnings

Warnings

For external use only

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Do Not Use

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away.

Indications & Usage

Directions

  • wash affected area and dry thoroughly
  • apply 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if conditions persist longer, ask 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

Storage And Handling

Other information

  • lot no. & exp. date: see box or see crimp of the tube
  • store between 20°C to 25°C (68°F to 77°F)

Inactive Ingredient

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monorask sodium phosphate dilhydrate, propylene glycol, purified water, white petrolatum

Dosage & Administration

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES INC.

10401 MONROE RD.

MATTHEWS, NC 28105 USA

* Please review the disclaimer below.