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 27, 2010

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  • Purpose

    Antifungal

  • Uses

    • clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevnet most athlete's foot from recurring when used daily
    • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking
  • Warning

    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 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 right away.

  • 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
    • 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 of twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • Other Information

    • store between 2° and 30°C (36° and 86°F)

  • Inactive ingredients

    Carbomer, Cetyl alcohol, Cholesterol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

  • Principal Display Panel

    Tolnaftateimage of carton label

  • Active Ingredients

    Tolnaftate 1%

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Stearic acid (UNII: 4ELV7Z65AP)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0057-11 in 1 BOX
    128 g in 1 TUBE
    2NDC:51141-0057-61 in 1 BOX
    220 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/27/2010
    Labeler - NeoPharm Co., Ltd. (631101883)
    Registrant - NeoPharm Co., Ltd. (631101883)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture
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