Label: TINACTIN ANTIFUNGAL- tolnaftate aerosol, powder

  • Category: HUMAN OTC DRUG LABEL

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.

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Updated September 14, 2023

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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, Isobutane, PPG-12-Buteth-16, SD Alcohol 40-B (10.5% v/v),Talc

  • Questions?

    1-866-360-3266

  • PRINCIPAL DISPLAY PANEL - 133 g Can Label

    NDC 11523-4162-1

    TOUGH ACTIN' ®

    Tinactin     ®

    ANTIFUNGAL

    tolnaftate

    Cures and

    prevents most

    athlete's foot

    DEODORANT

    POWDER SPRAY

    fights odor all day

    Relieves itching & burning

    NET WT 133g (4.6 oz)

    Can image

  • INGREDIENTS AND APPEARANCE
    TINACTIN   ANTIFUNGAL
    tolnaftate aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4162
    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
    ISOBUTANE (UNII: BXR49TP611)  
    PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
    TALC (UNII: 7SEV7J4R1U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Colorwhite (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4162-1133 g in 1 CAN; Type 0: Not a Combination Product02/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/28/2014
    Labeler - Bayer HealthCare LLC. (112117283)
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