Label: UP AND UP 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 July 8, 2020

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    •
    proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
    •
    helps prevent most athlete’s foot with daily use
    •
    for effective relief of itching, burning and 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 puncture 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    •
    use daily for 4 weeks; if condition persists 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?

    1-888-547-7400

  • Principal Display Panel

    Compare to active ingredient in Tinactin® Liquid Spray

    soothing

    antifungal liquid spray

    tolnaftate 1%

    cures and prevents most athlete’s foot

    helps relieve itching and burning

    NET WT 5.3 OZ (150 g)

    Antifungal Liquid Spray Label
  • INGREDIENTS AND APPEARANCE
    UP AND UP ANTIFUNGAL 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-154
    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
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Product Characteristics
    ColorYELLOW (hazy yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-154-731 in 1 CARTON06/28/2017
    1150 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/28/2017
    Labeler - Target Corporation (006961700)
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