Label: TOLNAFTATE - tolnaftate cream

  • NDC Code(s): 53210-1001-0
  • Packager: Morales Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active ingredient (in each gram)

    Tolnaftate 1 percent

    Close
  • Purpose

    Antifungal

    Close
  • 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
    Close
  • Warnings

    For external use only

    When using this product avoid contact with the eyes

    Close
  • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
    Close
  • Do not use

    on children under 2 years of age except under the advice and supervision of a doctor.

    Close
  • Keep out of reach of children.

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

    Close
  • 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
    Close
  • Other information

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

    Close
  • Inactive ingredients

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

    Close
  • 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

    Close
  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE  
    tolnaftate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53210-1001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE C  
    CETYL ALCOHOL  
    CHLOROCRESOL  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    LIGHT MINERAL OIL  
    WATER  
    STEARIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53210-1001-0 1 in 1 BOX
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 09/25/2012
    Labeler - Morales Distributors, Inc. (127151731)
    Close