Label: FUNGISOLVE TOLNAFTATE ANTIFUNGAL- tolnaftate spray

  • 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 April 30, 2016

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

  • 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

  • Flammable

    Do not use while smoking or near heat or flame.

  • 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, intentional misuse by deliberately concentrating and inhaling the content can be harmful or fatal.
    • 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
    • spray a thin layer over the 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.
    • 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

    Aloe vera, alpha-tocopherol, franfrance, Isopropyl alcohol, Polyethylene Glycol, purified water, sodium m-bisulfite.

  • 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) SPRAY

    Label Image
  • INGREDIENTS AND APPEARANCE
    FUNGISOLVE TOLNAFTATE ANTIFUNGAL 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-104
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70242-104-0144 mL in 1 BOTTLE, SPRAY; 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(70242-104)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(70242-104)