Label: SIGNATURE CARE ATHLETES FOOT- 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 January 24, 2017

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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
    •
    in case of clogging, clean nozzle with pin
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    alcohol denat., aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

  • Questions or comments?

    1-888-723-3929

  • Principal Display Panel

    Athlete’s Foot Spray

    Tolnaftate 1%

    Antifungal

    POWDER SPRAY

    COMPARE TO Tinactin® Powder Spray active ingredient

    Relieves itching and burning

    Cures and prevents most athlete’s foot

    NET WT 4.6 OZ (130 g)

    Signature Care Athlete's Foot Spray
  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE ATHLETES FOOT 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-205
    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
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TALC (UNII: 7SEV7J4R1U)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-205-90130 g in 1 CAN; Type 0: Not a Combination Product10/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/11/2015
    Labeler - Safeway (009137209)
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