FDA Label for Personal Care Antifungal

View Indications, Usage & Precautions

Personal Care Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Personal Care Products, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



* Please review the disclaimer below.