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 August 23, 2010

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

  • Tolnaftate

    Active ingredient

    Tolnaftate 1%

  • PURPOSE

    Purpose

    Antifungal

    Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • proven effective in the prevention of athlete's foot with daily use
    • for effective relief of chafing associated with jock itch
    • soothes itchy, scaly skin between the toes and itchy, burning feet
  • WARNINGS

    Warnings

    For external use only

  • INDICATIONS & USAGE

    When using this product avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks (for jock itch) or 4 weeks (for athlete's foot and ringworm)
  • DO NOT USE

    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

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information

    store between 2o and 30oC (36o and 86oF)

    Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

    Inactive ingredients

    butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purfied water, sorbitan monostearate, stearyl alcohol

  • QUESTIONS

    Questions?

    Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30PM.

  • PRINCIPAL DISPLAY PANEL

    Image of Tolnaftate Cream Carton Label

    Image of Tolnaftate Cream Tube Label

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Ceteth-20 (UNII: I835H2IHHX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51852-102-011 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/01/2010
    Labeler - LIFElabs, a Division of Atico International, USA, INC. (073876450)