Label: ANTI-FUNGAL- tolnaftate powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 April 30, 2018

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  • Active Ingredient

    Tolnaftate 1 %

  • Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • for effective treatment of most athlete's foot (tinea pedis) and jock itch (tinea cruris)
    • relieves itching, scaling, burning, irritation and discomfort
    • clears up most athlete's foot infection and, with daily use, helps to keep it from coming back
  • Warnings

    For external use only

    Do not use on children under 2 years of age.

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if 

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot) or within 2 weeks (for jock itch)
  • Keep out of reach of children.


    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well before use
    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • this product is not effective on the scalp or nails

    For athletes foot

    • use daily for 4 weeks 
    • pay special attention to the spaces between the toes
    • wear well-fitting, ventilated shoes
    • change shoes and socks at least once a daily
    • to prevent athlete's foot: clean and dry feet thoroughly, apply once or twice daily

    For jock itch

    • use daily for 2 weeks
  • Other information

    store between 2° - 30° C (36° - 86° F)

  • Inactive ingredients

    starch, talc

  • Package Label Display

    Anti-Fungal Powder Label

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL 
    tolnaftate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE.45 g  in 45 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-123-4545 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-123)
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