Label: TOLNAFTATE CREAM 1% ANTIFUNGAL- family wellness tolnaftate cream

  • NDC Code(s): 69396-042-05
  • Packager: Trifecta Pharmaceuticals USA, LLC
  • 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 January 17, 2023

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Anti-Fungal

  • KEEP OUT OF REACH OF CHILDREN

  • 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.

    When using this product avoid contact with the eyes.

    Stop use and ask a healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

  • Directions

    ● wash affected area and dry thoroughly

    ● apply 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 daily.

    ● use daily for 4 weeks; if conditions persists 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.

  • Inactive ingredients

    Cetyl alcohol, ethylparaben, glycerol, light mineral oil, glycerol monostearate, petrolatum, purified water, sodium dodecyl sulfate

  • Other information

    ● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

    500 VOLVO PARKWAY, CHESAPEAKE, VA. 23320

    NOT SATISFIED?

    Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

    This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin®

  • PRINCIPAL DISPLAY PANEL

    family wellness tolnaftate 05oz.

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE CREAM 1% ANTIFUNGAL 
    family wellness tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-042
    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
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-042-051 in 1 BOX08/30/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/30/2019
    Labeler - Trifecta Pharmaceuticals USA, LLC (079424163)
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