Xtracare Antifungal Foot
FDA Label NDC 57337-056

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Antifungal Foot (NDC 57337-056). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, 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

Use

  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • if used daily, can prevent recurrence of athlete's foot
  • relieves symptoms of athlete's foot, including itching, burning and cracking

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

Indications & Usage

XtraCare® Antifungal Foot Spray

For Athlete's Foot

Tolnaftate 1%

  • Relieves Itching & Burning
  • Cures & Prevents Most Athlete's Foot
  • Fights Odor All Day

    • *Compare to the Active Ingredient in Tinactin®

    CAUTION  Contents under pressure - Read precautions on back panel.

    Net Wt 3.5 Oz (100g)

Warnings

Warnings

For external use only.

Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF (49oC).

When using this product

  • avoid eyes & face
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement after 4 weeks

Dosage & Administration

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 betwen the toes; wear well-fitted, ventilated shoes and change shoes and socks at least once a day.
  • use daily for 4 weeks; if condition persists longer, consult a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and night)
  • in case of clogging, clean nozzle with a pin

Inactive Ingredient

Inactive Ingredients

butane, propane, alcohol, butylated hydroxytoluene, talc.

Other Safety Information

Other information store between 68o to 77oF (20o to 25oC)

Questions/Comments? 1-855-345-5575

*This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin®

DISTRIBUTED BY

REJOICE INTERNATIONAL, INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

* Please review the disclaimer below.