Label: SMART SENSE TOLNAFTATE ANTIFUNGAL- 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 23, 2014

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  • ACTIVE INGREDIENT

    Active ingredient                                              Purpose

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

  • PURPOSE

    Uses

    • proved 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
    • effectively soothes and relieves itching associated with jock itch, scaly skin between
  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR

    Stop use and ask a doctor if

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

    Do not use on children under 2 years og 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 Poision Control Center right away. (1-800-222-1222) 

  • 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 chage 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

    Lot No. & Exp. Date: see box or see crimp of the tube. Store between 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    Kmart Corporation

    Hoffman Estates, IL 60179

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SMART SENSE TOLNAFTATE ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-424
    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)  
    CETETH-20 (UNII: I835H2IHHX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-424-141 in 1 CARTON
    114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/23/2014
    Labeler - Kmart Corporation (008965873)
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