Label: SMARTSENSE MAXIMUM STRENGTH ATHLETES FOOT RELIEF ANTIFUNGAL- tolnaftate spray

  • NDC Code(s): 23667-815-01
  • Packager: Formulated Solutions, 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 January 23, 2017

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlet's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief if itching, burning, cracking
  • Warnings

    For external use only

    Flammable: Do not use while smoking or near heat or flame

    Do not use

    on children under 2 years of age unless directed by a doctor

    When using this product

    • avoid contact with the eyes
    • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
    • contents under pressure. Do not punture or incinerate. Do not store at temperature above 120°F (49°C).

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • wash affected area and dry thoroughly
    • shake can well and spray 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 toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily
    • use daily for 4 weeks; if condition persist 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
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive Ingredients

    alcohol denat, butylated hydroxytoluene, isobutane, polyethylene glycol 300, polysorbate 20

  • Questions or comments?

    1-800-719-9260

  • Package Labeling:

    SmartSense 815

  • INGREDIENTS AND APPEARANCE
    SMARTSENSE MAXIMUM STRENGTH ATHLETES FOOT RELIEF ANTIFUNGAL 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-815
    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
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23667-815-01150 g in 1 CAN; Type 0: Not a Combination Product01/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/23/2017
    Labeler - Formulated Solutions, LLC (143266687)
    Establishment
    NameAddressID/FEIBusiness Operations
    Formulated Solutions, LLC143266687manufacture(23667-815)
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