Label: RUGBY TOLNAFTATE 1% POWDER 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 November 18, 2022

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    . For effective treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)

    . Relieves itching, scaling, irritation, and discomfort

    . Clears up most athlete's foot infection and helps keep it from coming back with daily use

  • 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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • Directions

    . Shake well before using

    . Clean the affected area and dry thoroughly

    . Apply a thin layer of product over the affected area twice a day (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 Athlets's 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 daily

    . To prevent athlete's foot: clean the feet and dry thoroughly, apply once or twice daily

    For Ringworm

    Use daily for 4 weeks

  • Other Information

    Store between 2°-30ºC (36°-86°F)

  • Inactive Ingredients

    Talc, Corn Starch

  • Questions and Comments?

    1-800-645-2158

  • Label

    CR-371081 IN MASTER

  • INGREDIENTS AND APPEARANCE
    RUGBY TOLNAFTATE 1% POWDER 
    rugby tolnaftate 1% powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1329
    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
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1329-2624 in 1 CASE05/10/2021
    145 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/10/2021
    Labeler - Rugby Laboratories (079246066)
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