Label: LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT- tolnaftate powder

  • NDC Code(s): 20276-108-57, 20276-108-85
  • Packager: Delta Brands, Inc
  • 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 June 3, 2022

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    ■ proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) ■ helps prevent most athlete's foot with daily use ■ for effective relief of itching, burning, and cracking

  • Warnings

    For external use only

    Flammable: Do not use while smoking or near heat or flame

  • Do not use

    on children under 2 years of age unless directed by a doctor

  • When using this product

    ■ avoid contact with eyes ■ use only as directed. Intentional misuse by deliberetely concentrating and inhaling contents can be harmful or fatal ■ contents under pressure. Do not puncture or incinerate.

    Do not stire at a temperature above 120ºF (49ºC​)

  • 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 right away

  • Directions

    ■ wash affected area and dry thoroughly ■ shake can well and spray a thin 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day ■ use daily for 4 weeks, if conditions persist longer, ask a doctor ■ to prevent athlete's foot, apply once or twice daily (morning and/or night) ■ this product is not effective on the scalp or nails ■ in case of clogging, clean nozzle with pin

  • Other information

    ■ store between 68º to 77ºF (20º to 25ºC)

  • Inactive ingredients

    alcohol denat., butane, fragrance, propane, triethanolamine, zea mays (corn) starch

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPER SOFT ANTIFUNGAL  FOR ATHLETES FOOT
    tolnaftate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-108
    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)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-108-8585 g in 1 CAN; Type 0: Not a Combination Product02/19/2018
    2NDC:20276-108-5757 g in 1 CAN; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/19/2018
    Labeler - Delta Brands, Inc (102672008)