FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) LIQUID [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]

FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) LIQUID [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]
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NDC 70242-106-01
Set ID 65927394-abb7-406f-ac5f-5fd85e80aada
Category HUMAN OTC DRUG LABEL
Packager Dannso Corp./d.b.a. Essential Products
Generic Name
Product Class
Product Number
Application Number PART333C
  • Active Ingredients

    Tolnaftate 1%


  • Purpose

    Antifungal

  • Uses

    cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)

    relieves sympotoms of athelete's foot including itching, burning, cracking and scaling.

  • Warnings

    For external use only use only as directed

  • Do not use

    • children under 2 years of age unless directed by a doctor
  • When using this product

    • avoid contact with the eyes or mouth
    • use only as directed
  • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athelete's foot and ringworm) or 2 weeks (for jock itch)
  • Keep out of reach of children.

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

  • Directions

    • wash the affected area and dry thoroughtly
    • apply a thin layer over the affected area twice daily morning and night
    • supervice 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 a day.
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • if the condiotion persists longer, ask a doctor
    • this product is not effective on scalp or nails
  • Other Information

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

    Tamper evident do not accept if safety seal is broken or missing.

  • Inactive Ingredients

    Butylated hydroxyanisole, DMDM Hyantoin, Ethoxydiglycol, Eucaliptu oil, Glycerin, Methyl Sallicylate, Pepermint oil, Polyethylene Glycol, Propylen glycol.

  • Questions or Comments?

    Call 305 2618762 M-F 9AM to 4PM Eastern Time

  • Distributed by:

    Essential Productd Miami, FL, 33126 www.essentialproductsusa.com

  • FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE)

    Label Image
  • INGREDIENTS AND APPEARANCE
    FUNGISOLVE TOLNAFTATE ANTIFUNGAL 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70242-106-0130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product04/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/16/2011
    Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
    Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dannso Corp./d.b.a. Essential Products059741071LABEL(70242-106)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(70242-106)

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