Label: TOLNAFTATE cream

  • 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 September 28, 2012

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  • Active ingredient (in each gram)

    Tolnaftate 1 percent

  • Purpose

    Antifungal

  • Uses

    • clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot from recurring when used daily
    • effectively soothes and relieves symptoms of athlete's foot, including 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.

  • Keep out of reach of children.

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

  • 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 attentional 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 condition persists longer ask a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and night)
    • this product is not effective on the scalp or nails
  • Other information

    store between 2 degrees and 30 degrees Celsius (36 degrees and 86 degrees Fahrenheit)

  • Inactive ingredients

    carbomer 940, cetyl alcohol, chlorocresol, dibasic sodium phosphate hydrate, glycerin, glyceryl monostearate, light liquid paraffin, purified water, and stearic acid

  • Package label


    NDC NO. 53210-1001-0
    Tolnafate 1 percent
    Cream USP 1 percent Antifungal

    Relieves Itching and Burning

    Cures and Prevents Athlete's Foot

    Prevents and Relieves Itching and Redness

    Anti-Itch Cream for Skin Irritations

    Compare to Tinactin (R) active ingredient
    This product is n ot manufactured or distributed by Schering-Plough Healthcare Products, Inc. owner of the registered Trademark Tinactin

    Maximum Strength

    Net 1 oz(28.3g)

    Exclusively distributed by:
    Morales Distributors, Inc
    Mayaguez, P.R. 00682

    Made in Korea

    box label

    box label

    tube label

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE  
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53210-1001
    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
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53210-1001-01 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/25/2012
    Labeler - Morales Distributors, Inc. (127151731)