Label: GLADIATOR BARRIER ACTIVATOR- lactic acid liquid

  • NDC Code(s): 48106-1155-1, 48106-1155-2, 48106-1155-3, 48106-1155-4, view more
    48106-1155-5, 48106-1155-6
  • Packager: BouMatic, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 1, 2012

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    CHLORINE DIOXIDE TEAT DIP ACTIVATOR

    Helps reduce the spread of organisms
    which may cause Mastitis

    USE DIRECTIONS

    NOT FOR HUMAN USE
    FOR EXTERNAL USE ONLY

    Do not mix with any chemicals other than
    GLADIATOR™ BARRIER BASE.

    In a well-ventilated area, mix equal parts
    GLADIATOR™ BARRIER BASE and GLADIATOR
    ™ BARRIER ACTIVATOR. After mixing,
    the ready-to-use product will yield a 1%
    Chlorine Dioxide solution. Do not mix more
    product than will be used in 24-hours.

    POST-DIPPING: After milking, dip entire
    teat with this product. Allow to air dry.
    Note: If solution in cup becomes visibly
    dirty, replenish with a fresh mixture of this
    product.

    Do not return unused product to original
    container.

    Active Ingredient (Lactic Acid 1%)
    Emollients (Glycerin 8%, Sorbitol 8%)

  • CAUTION

    CAUTION

    KEEP OUT OF REACH OF CHILDREN

    NOT FOR HUMAN USE

    FIRST AID:
    If in eyes: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses,
    if present after the first 5 minutes, then continue rinsing. Contact a physician immediately.

    If swallowed: Have person sip a glass of water if able to swallow. Do not give anything to an unconscious person. Do not
    induce vomiting. Contact a physician immediately.

    If breathing difficulty occurs: Move person to fresh air.  Contact a physician immediately.

    If on skin: Take off contaminated clothing. Rinse skin with soap and water.  If irritation develops and persists, contact a physician.

    Have the product container or label with you when going for treatment, calling a physician, the emergency
    number listed on this label or MSDS, or a poison control center.

    PRECAUTION: Avoid eye contact. Do not ingest. Do not mix with any chemicals except as directed.

    STORAGE: Store in a closed container away from sources of heat. If product becomes frozen, thaw and mix
    well before use.

    SEE MATERIAL SAFETY DATA SHEET
  • PRINCIPAL DISPLAY PANEL

    blank label

  • INGREDIENTS AND APPEARANCE
    GLADIATOR BARRIER ACTIVATOR 
    lactic acid liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:48106-1155
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID88 mL  in 10 L
    Inactive Ingredients
    Ingredient NameStrength
    UREA (UNII: 8W8T17847W) 100 mL  in 10 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48106-1155-5208 L in 1 DRUM
    2NDC:48106-1155-61040 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    3NDC:48106-1155-13.8 L in 1 DRUM
    4NDC:48106-1155-218.9 L in 1 DRUM
    5NDC:48106-1155-356.8 L in 1 DRUM
    6NDC:48106-1155-4114 L in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2012
    Labeler - BouMatic, LLC (124727400)
    Registrant - BouMatic, LLC (124727400)
    Establishment
    NameAddressID/FEIBusiness Operations
    BouMatic, LLC124727400api manufacture