Label: CVS ATHLETES FOOT CREAM TOLNAFTATE - tolnaftate cream 

  • 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 02/13

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

  • ACTIVE INGREDIENT

    Active Ingredient                                                                              Purpose

    Tolnaftate 1% .................................................................................Antifungal

    Close
  • PURPOSE

    Uses

    • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • proven effective in the prevention of athlete's foot with daily use
    • effectively relief of itching, burning and cracking
    Close
  • WARNINGS

    Warnings

    For external use only

    Close
  • WHEN USING

    When using this product avoid contact with the eyes.

    Close
  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
    Close
  • DO NOT USE

    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

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • INDICATIONS & USAGE

    Directions

    • Wash affected area and dry thoroughly
    • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
    • 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
    • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.  If condition persists longer consult a doctor
    • This product is not effective on the scalp or nails
    Close
  • STORAGE AND HANDLING

    Other Information

    Store between 20o to 25oC (68o to 77oF)

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Propylene glycol, liquid paraffin, stearyl alchol, cetyl alcohol, sorbitan monstearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben.

    Close
  • DOSAGE & ADMINISTRATION

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    www.cvs.com

    Made in Korea

    Close
  • INGREDIENTS AND APPEARANCE
    CVS ATHLETES FOOT CREAM TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-522
    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
    PROPYLENE GLYCOL  
    MINERAL OIL  
    STEARYL ALCOHOL  
    CETYL ALCOHOL  
    SORBITAN MONOSTEARATE  
    WATER  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-522-28 1 in 1 CARTON
    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 01/31/2013
    Labeler - CVS PHARMACY (062312574)
    Close