LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT (TOLNAFTATE) POWDER [DELTA BRANDS, INC]

LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT (TOLNAFTATE) POWDER [DELTA BRANDS, INC]
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NDC 20276-108-57, 20276-108-85
Set ID 6636da6a-9e51-25ad-e053-2a91aa0a60d2
Category HUMAN OTC DRUG LABEL
Packager Delta Brands, Inc
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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 Product04/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/19/2018
    Labeler - Delta Brands, Inc (102672008)

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