UP AND UP SOOTHING ANTIFUNGAL (TOLNAFTATE) LIQUID [FORMULATED SOLUTIONS, LLC]

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UP AND UP SOOTHING ANTIFUNGAL (TOLNAFTATE) LIQUID [FORMULATED SOLUTIONS, LLC]
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NDC 23667-816-01
Set ID 46c63c9a-d471-382e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Formulated Solutions, LLC
Generic Name
Product Class
Product Number
Application Number PART333C
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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:

    Up and Up 816

  • INGREDIENTS AND APPEARANCE
    UP AND UP SOOTHING ANTIFUNGAL 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-816
    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:23667-816-01150 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(23667-816)
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