Label: BLISTEX ODOR-EATERS POWDER- tolnaftate spray

  • NDC Code(s): 10157-4645-1, 10157-4645-2
  • Packager: Blistex 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 December 17, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in liquid)

    Tolnaftate 1% (to deliver)

  • Purpose

    Antifungal

  • Uses

    • prevents most athlete's foot with daily use
    • clears up most athlete's foot infection and with daily use helps keep it from coming back
  • Warnings

    Do not use on children under 2 years of age unless directed by a doctor.

    For external use only.

    Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

    If irritation occurs, discontinue use and consult a doctor.

    Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    Do not use near fire or flame – flammable mixture.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake container well before use.
    • To prevent athlete's foot, wash the feet and dry thoroughly. Holding can 8" from the skin, spray a thin layer of the product on the feet once or twice daily (morning and/or night). Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • Wash hands after use.
  • Inactive ingredients

    disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate, sodium polyacrylate (crosslinked)

  • PRINCIPAL DISPLAY PANEL - 113 g Can Label

    Odor-
    Eaters®

    3
    ADVANCED
    ODOR/WETNESS
    FIGHTERS

    TALC-FREE
    SPRAY
    POWDER
    Tolnaftate Antifungal

    Destroys Odor & Prevents
    Most Athlete's Foot

    STOPS
    ODOR

    ALL-DAY
    EFFECTIVENESS®

    Net Wt.
    4 oz. (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Can Label
  • INGREDIENTS AND APPEARANCE
    BLISTEX   ODOR-EATERS POWDER
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-4645
    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
    ISOBUTANE (UNII: BXR49TP611)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-4645-1113 g in 1 CAN; Type 0: Not a Combination Product12/09/2013
    2NDC:10157-4645-2151 g in 1 CAN; Type 0: Not a Combination Product11/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C12/09/2013
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-4645)
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