Label: TOLNAFTATE CREAM 1%- tolnaftate cream

  • NDC Code(s): 68016-152-01
  • Packager: Pharmacy Value Alliance, LLC.
  • 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 May 9, 2023

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  • Drug Facts

  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Anti-Fungal

  • Uses

    • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
    • Helps prevent most athlete's foot with daily use
    • For effective relief of itching, burning, and cracking
  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Warnings

    For External Use Only

    When using this product avoid contact with the eyes

    Do not use on children under 2 years of age except under the advice and supervision of a doctor

  • 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 or twice daily (morning and/or night)
    • This product is not effective on the scalp or nails
  • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
  • Other Information

    • Store between 20° to 25°C (68° to 77°F)
    • Lot No & Expiration Date: See box or crimp of tube
  • Inactive ingredients:

    Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate

  • Soothes Itching, Burning and Cracking

    Distributed By:

    Pharmacy Value Alliance, LLC.

    407 East Lancaster Avenue, Wayne, PA. 19087 USA

    www.emersongroup.com

  • Packaging

    Anti-Fungal Cream

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE CREAM 1% 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-152
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-152-011 in 1 BOX08/31/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/23/2016
    Labeler - Pharmacy Value Alliance, LLC. (101668460)
    Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)
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