Label: BIO-GROOM- boric acid and salicylic acid solution

  • NDC Code(s): 46521-003-01, 46521-003-04, 46521-003-08, 46521-003-28
  • Packager: Bio-Derm Laboratories Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 10, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Boric acid 0.80%Antibacterial
    Salicylic acid 0.20%Antiseptic ear cleaner
  • Uses

    to routinely remove dirt and dissolve ear wax buildup.

  • Warnings

    For external use only on dogs and cats

    Ask a veterinarian before use if your pet has

    • painful ear condition
    • discharge
    • broken or abraded skin

    When Using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a veterinarian if

    • condition worsens or does not improve after use of this product as directed.

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

  • Directions

    • shake well
    • apply generously to each ear. Gently massage ears until dirt and wax are dissolved.
    • Allow pet to shake its head to dispel accumulation and swab ears with cotton.
    • For best results, use twice a month or after each bath and before and after swimming or as directed by a veterinarian.
  • Inactive ingredients

    water, isopropyl alcohol, polysorbate 60, eucalyptol.

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    bio-derm®
    LABORATORIES, INC.
    P.O.BOX 8070,
    LONGVIEW, TX 75607 USA

  • PRINCIPAL DISPLAY PANEL - 3.8L Bottle Label

    BIO-GROOM®

    EAR-CARE™
    NON-OILY NON-STICKY

    EAR
    CLEANER

    Gently cleans and dries the ear
    canal. Removes excessive
    wax build-up.

    PRINCIPAL DISPLAY PANEL - 3.8L Bottle Label
  • INGREDIENTS AND APPEARANCE
    BIO-GROOM   EAR-CARE
    boric acid and salicylic acid solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46521-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID0.8 mg  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46521-003-04118 mL in 1 BOTTLE
    2NDC:46521-003-08236 mL in 1 BOTTLE
    3NDC:46521-003-0129 mL in 1 BOTTLE
    4NDC:46521-003-283800 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/10/1985
    Labeler - Bio-Derm Laboratories Inc. (057405219)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Derm Laboratories Inc.057405219MANUFACTURE
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