Label: PERSONAL CARE ANTIFUNGAL- tolnaftate spray

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 1, 2015

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  • 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


  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE ANTIFUNGAL  
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-0035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    BUTANE (UNII: 6LV4FOR43R)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-0035-3100 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/21/2010
    Labeler - Personal Care Products, Inc. (966155082)