Label: TOLNAFTATE CREAM 1% ANTIFUNGAL- tolnaftate cream

  • NDC Code(s): 70000-0084-1
  • Packager: CARDINAL HEALTH 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Anti-Fungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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 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.

  • Inactive ingredients

    Cetostearyl alcohol, ethylparaben, glycerol, light mineral oil, monostearin, 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.

  • Questions or Comments?

    1-888-296-9067

  • Distributed By

    Distrubuted By Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    1-800-200-6313

    Essential to Care since 1979

    Made in China

    2021 Cardinal Health. All rights reserved Cardinal Health, the Cardinal Health LOGO, ESSENTIAL TO CARE and Leader LOGO are trademarks or registered Trademarks of Cardinal Health. All other marks are the property of their respective owners.

    All Leader Brand products have a 100% Money Back Guarantee

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

  • Packaging

    CAH LDR Antifungal Cream 1oz

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE CREAM 1% ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0084
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0084-11 in 1 BOX02/11/2021
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/11/2021
    Labeler - CARDINAL HEALTH 110 dba LEADER (063997360)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)