Label: TINACTIN- tolnaftate aerosol, 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 June 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    Avoid contact with the eyes

    When using this product

    • 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.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    Do not use on children under 2 years of age unless directed by a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    alcohol denat. (29% v/v), butylated hydroxytoluene, isobutane, PPG-12-buteth-16

  • Questions?

    1-866-360-3266

  • PRINCIPAL DISPLAY PANEL - 150g Can Label

    NDC 11523-0165-3

    TOUGH ACTIN'

    Tinactin
    ®

    ANTIFUNGAL

    tolnaftate

    Cures and

    prevents most

    athlete's foot

    LIQUID SPRAY

    cools the burn

    Relieves itching & burning

    NET WT 150g (5.3 oz)

    Liquid spray label

  • INGREDIENTS AND APPEARANCE
    TINACTIN 
    tolnaftate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0165
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0165-3150 g in 1 CAN; Type 0: Not a Combination Product09/23/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/23/1993
    Labeler - Bayer HealthCare LLC (112117283)