Label: ANTIFUNGAL FOOT CARE- 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 24, 2019

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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?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient of Tinactin® Antifungal Liquid Spray

    ANTIFUNGAL LIQUID SPRAY

    tolnaftate 1%

    cools the burn

    relieves itching and burning

    cures and prevents most athlete’s foot

    NET WT 5.3 OZ (150 g)

    154-83-antifungal-liquid-spray.jpg
  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL  FOOT CARE
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0154
    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
    ISOBUTANE (UNII: BXR49TP611)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0154-1150 g in 1 CAN; Type 0: Not a Combination Product09/24/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/24/2004
    Labeler - Rite Aid Corporation (014578892)