Label: TINACTIN- tolnaftate cream 

  • NDC Code(s): 11523-0934-2
  • Packager: MSD Consumer Care, 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 05/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Tolnaftate 1%

    Close
  • Purpose

    Antifungal

    Close
  • Uses

    • cures most jock itch (tinea cruris)
    • for effective relief of itching, chafing and burning
    Close
  • 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 2 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.

    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
    • use daily for 2 weeks; if condition persists longer, ask a doctor
    • this product is not effective on the scalp or nails
    Close
  • Other information

    store between 20° to 25°C (68° to 77°F)

    Close
  • Inactive ingredients

    ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

    Close
  • Questions?

    1-866-360-3266

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary
    of Merck & Co., Inc., Whitehouse Station, NJ USA.

    Close
  • PRINCIPAL DISPLAY PANEL - 15g Tube Carton

    Tinactin®
    tolnaftate
    ANTIFUNGAL

    CREAM

    Relieves:

    • itching
    • burning
    • chafing

    NET WT
    15g (1/2 oz)

    PRINCIPAL DISPLAY PANEL - 15g Tube Carton
    Close
  • INGREDIENTS AND APPEARANCE
    TINACTIN 
    tolnaftate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11523-0934
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tolnaftate (Tolnaftate) Tolnaftate 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ceteth-20  
    cetostearyl alcohol  
    chlorocresol  
    mineral oil  
    propylene glycol  
    water  
    sodium phosphate, monobasic  
    petrolatum  
    Product Characteristics
    Color WHITE (White to Off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-0934-2 1 in 1 CARTON
    1 15 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 09/23/1993
    Labeler - MSD Consumer Care, Inc. (968091715)
    Close