Label: TINEACIDE- tolnaftate liquid

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

Drug Label Information

Updated December 21, 2023

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  • Active Ingredients

    Drug facts

    Active Ingredient

    TOLNAFTATE 1%

  • Purpose

    Purpose

    Antifungal

  • Keep Out Of Reach Of Children

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

  • Indications

    Indications

    • Cures most athlete's foot (tinea pedis).
    • Cures most jock itch (tinea cruris) and ring worm (tinea corporis).
    • Relieves itching, cracking, burning, and scaling which accompany these conditions.
    • Prevents most athlete's foot (tinea pedis) with daily use.
  • Warnings

    Warnings

    • Do not use
    • on children under 2 years of age unless directed by a physician
    • in or near mouth or eyes
    • for vaginal yeast infections
    • For external use only
  • When Using This Product

    When using this product avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water.

  • Stop Use And Consult A Physician

    Stop use and ask a physician if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

  • Directions

    Directions

    • Wash the affected ares with soap and water and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a physician.
    • 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.
    • For athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks. If condition persists longer, consult a physician.
    • wash hands after each use.
  • Other Information

    Other Information

    • Store at room temperature.
  • Questions?

    Questions?

    Call (800)307-8818, Monday through Friday, 8:00 AM to 5:00 PM (Pacific Time).

  • Inactive Ingredients

    Inactive Ingredients

    Paraffnum Liquidum, Carthamus Tinctorius (Safflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Oreganum Vulgaris (Oregano) Leaf Oil, Tocopheryl acetate, BHT, BHA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylpapaben.

  • Package Label Tineacide Solution Physician Formula

    Blaine Labs

    TINEACIDE SOLUTION PHYSICIAN FORMULA

    Antifungal Treatment

    Dispensed Only by Physicians

    NDC: 63347-511-03

    15ml (1/2 oz.)

    Proudly Made in the USA

    Please Recycle! This package is made from recyclable materials.

    Exp. / Lot #

    Patent Pending

    Blaine Labs

    Manufactured by

    Blaine Labs, Inc

    11037 Lockport Place

    Sante Fe Springs, CA 90670

    27000-P-BX Rev. 20120921

    Blaine Tineacide Sol1

    res

  • INGREDIENTS AND APPEARANCE
    TINEACIDE  
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE140 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    JOJOBA OIL (UNII: 724GKU717M)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63347-511-0315 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/19/2012
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-511)
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