Label: TOLNAFTATE- tolnaftate 1% cream

  • NDC Code(s): 69396-130-01
  • Packager: Trifecta Pharmaceuticals USA, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Anti-Fungal

  • 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.

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center immediately

  • Warnings

    For external use only.

    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

    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.

  • Questions

    Call 1-800-883-0085

  • Inactive ingredients

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

  • Other information

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

  • Distrubuted by

    Proudly distributed by

    Associated Wholesale Grocers Inc

    Kansas City, Kansas 66106

    Tinactin® is a registered trademark of Bayer Inc.

    www.bestchoicebrand.com

  • Package Label

    Best Choice Tolnaftate Cream 1oz 050923 CDER

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-130
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-130-011 in 1 BOX06/30/2023
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/30/2023
    Labeler - Trifecta Pharmaceuticals USA, LLC (079424163)
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