Personal Care Antifungal
FDA Label NDC 29500-0035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products, Inc. for the product Personal Care Antifungal (NDC 29500-0035). 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 drug facts active ingredient, purpose, keep out of reach of children, uses, warnings, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

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.

Uses

  • 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

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 in temperature above 120°F (49°C).

When Using This Product

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

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement after 4 weks

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a this 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 the spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once 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

Other Information

store between 68° to 77°F (20° to 25°C)

Inactive Ingredients

alcohol, isobutane, perfume, propane, n-butane, talc powder.

Anti Fungal Powder Spray Label

PERSONAL CARE®

ANTIFUNGAL POWDER SPRAY
For Athlete's Foot

TOLNAFTATE 1%

*Compare to the Active Ingredients in Tinactin®

Cures and Prevents Most Athlete's Foot

Relieves Itching and Burning

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

Distributed by: Personal Care Products, Inc. Bingham Farms, MI 48025-3463

Made in China

Footspraypdp Label (Footspraypdp)

Footspraypdp Label (Footspraypdp)


* Please review the disclaimer below.