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

  • NDC Code(s): 46521-007-25
  • 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 July 13, 2011

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient Purpose
    Boric acid 0.8%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

    • Thoroughly clean inside ear and around the base of the ears. Squeeze Ear Care Pads to allow lotion to enter lower ear canal. Gently massage ears until dirt and wax are dissolved.
    • Allow pet to shake its head to dispel accumulation.
    • 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 - 160g Bottle Label

    BIO-GROOM®

    EAR CARE™

    NON OILY - NON STICKY

    EAR CLEANER PADS

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

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    BIO-GROOM   EAR-CARE EAR CLEANER
    boric acid and salicylic acid solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46521-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID0.8 mg
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 mg
    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:46521-007-2525 in 1 JAR
    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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