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

FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]
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NDC 70242-108-01
Set ID cc538c88-6887-4cb2-bd76-ec56cbd9b509
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)

    can prevent recurrence of most athlete's foot

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

  • Warnings

    For external use only

  • Do not use

    • children under 2 years of age unless directed by a doctor
    • on nails or scalp
    • in or near the mouth or the eyes
    • for vaginal yeast infections
  • Stop use and ask a doctor if

    too much irritation occurs or irratation gets worse

  • When using this product

    avoid contact with the eyes or mouth. If eye contacts occurs, rinse eyes thoroughtly with water.

  • Keep out of reach of children.

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

  • Directions

    • adults and children 12 years and over
    • wash the affected area and dry thoroughly
    • apply a thin layer over affected area twice daily morning and night
    • supervis 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.
  • Other Information

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

    do not accept if safety seal is torn broken or missing.

  • Inactive Ingredients

    Ceteareth-6, cety stearyl alcohol, methylparaben, mineral oil, PEG-20 cetyl/stearyl ether, propylene glycol, propylparaben, purified water, sodium m-bisulfite, stearyl alcohol.

  • Questions?

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

  • Distributed by:

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

  • FUNGISOLVE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM

    Label Image
  • INGREDIENTS AND APPEARANCE
    FUNGISOLVE TOLNAFTATE ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-108
    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
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70242-108-0128 g in 1 TUBE; 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(70242-108)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(70242-108)

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