Label: TINACTIN DEODORANT- tolnaftate aerosol, powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 30, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (To Deliver) 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 near heat, flame, or while smoking

    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 the contents can be harmful or fatal.
    • contents under pressure. do not puncture or incinerate. Do not store at temperatures above 120°F.

    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.

  • Directions

    • wash the 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

    butylated Hydroxytoluene, fragrance, hydroxypropyl cellulose, isobutane, kaolin, magnesium stearate, PPG-12-Buteth-16, SD Alcohol 40-B (9% v/v),zea mays (corn) starch

  • Questions?

    1-866-360-3266 or visit us at www.tinactin.com

  • PRINCIPAL DISPLAY PANEL - 133 g Can Label

    TOUGH ACTIN' ®



    Tinactin     ®

    tolnaftate ANTIFUNGAL


    CURES AND PREVENTS

    MOST ATHLETE'S FOOT

    Relieves:

    • Itching
    • Burning

    DEODORANT
    POWDER SPRAY

    Fights Odor

    Talc Free

    NET WT 133g (4.6 oz) PDP

  • INGREDIENTS AND APPEARANCE
    TINACTIN  DEODORANT
    tolnaftate aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0137
    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
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    KAOLIN (UNII: 24H4NWX5CO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0137-1133 g in 1 CAN; Type 0: Not a Combination Product03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/01/2024
    Labeler - Bayer HealthCare LLC. (112117283)
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