Label: FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ- 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 October 9, 2014

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                                                                        Purpose

    Tolnaftate 1%-----------------------------------------------------------------------------------------------Antifungal

  • PURPOSE

    Uses

    Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

    Helps preent most athlete's foot with daily use

    for effective relief of itching, burning and cracking

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation becomes severe
    • there is no improvement within 4 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 immediately.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • wash affected area and dry throughly
    • apply a thin layer over affected area twie daily (morning and night)
    • 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
    • use daily for 4 weeks; if condition persists longer, ask a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • OTHER SAFETY INFORMATION

    Other information

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

    Lot No. & Exp. Date;see box or see crimp of tube

  • INACTIVE INGREDIENT

    ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, propylene glycol, purified water, white petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    First Aid Research Corp.

    Wantagh, NY U.S. A. 11793

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-515
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75983-515-141 in 1 CARTON
    114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/09/2014
    Labeler - First Aid Reserach Corp (089405927)