Label: ANTIFUNGAL- tolnaftate 1% cream

  • NDC Code(s): 63868-685-01
  • Packager: Chain Drug Marketing Association 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 May 23, 2023

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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 doctorl 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, 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.

  • Distributed By

    Distributed By CDMA Inc.

    43157 W 9 Mile Road

    Novi, MI. 48375

    www.qualitychoice.com

    Questions: 800-935-2362

    Product of PRC

    This product is not manufactured or distributed by Bayer Health Care, LLC. distributor of Tinactin Antifungal Cream

  • PRINCIPAL DISPLAY PANEL

    antifungal cream tolnaftate 1oz

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    tolnaftate 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-685
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-685-011 in 1 BOX08/14/2020
    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 finalpart333C08/14/2020
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)
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