Label: ANTIFUNGAL- tolnaftate 1% cream

  • NDC Code(s): 83324-049-01
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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

View All Sections
  • 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 productavoid 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.

    Novi, MI. 48375

    www.qualitychoice.com

    Questions 800-935-2362

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

  • Label

    97529 QC TOLNAFTATE CREAM 1OZ REV06 042624 CDER

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    tolnaftate 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-049
    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:83324-049-011 in 1 BOX05/31/2024
    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 DrugM00508/14/2020
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!