Label: BLOAT GUARD- poloxalene powder

  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated January 2, 2019

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

  • SPL UNCLASSIFIED SECTION

    Medicated Top Dressing for Feed

    For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle

  • Active Ingredient

    Poloxalene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53%
    (Each 2/3 oz by weight of top dressing contains 10 g of poloxalene)

    Inert Ingredient:

    Verxite® #4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47%

  • CAUTION:

    For use in manufacturing medicated animal feeds only.

  • CAUTION:

    Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

    Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

  • STORE AT ROOM TEMPERATURE

  • Directions for Use as Top Dress on Feed

    Use the enclosed measure which is equal to 1/4 of a standard measuring cup and holds approximately 2/3 oz of Bloat Guard by weight. Each 2/3 oz by weight contains 10 g of poloxalene (the active drug ingredient).

    Daily Dosage

    Animal Weight (lb) Number of Measures

    Less than 500 . . . . . . . . . . . . . . . . . . . . . . . 1/2–1

    500–1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–2

    1000–1500 . . . . . . . . . . . . . . . . . . . . . . . . 1 1/2–3

    Over 1500 . . . . . . . . . . . . . . . . . . . . . . .. . . . . 2–4

    Bloat Guard is to be consumed daily. Bloat Guard should be fed as a top dressing on individual rations of ground feed, starting 2 or 3 days before animals are exposed to bloat-producing conditions. The higher dosage levels are recommended when bloat-producing conditions are severe.

    Repeat the feeding of Bloat Guard when animals are exposed to bloatproducing conditions more than 12 hours from the last feeding of Bloat Guard, but do not exceed the higher dosage levels in any 24-hour period.

    If your animals do not accept Bloat Guard readily, stir the recommended amount into their feed. After animals become accustomed to the change in diet, use Bloat Guard as a top dressing.

    Caution: It is essential that each animal consumes the total recommended dosage of Bloat Guard daily for adequate protection.

  • Warning:

    The normal life of this product is at least 24 months. However, when the product is subjected to extreme temperatures (38°C/100°F) for long periods of time (6 months), spontaneous combustion may occur. The product is not combustible unless it develops a strong, irritating odor; if this occurs, flush with water and discard immediately.

    NOT FOR HUMAN USE

  • SPL UNCLASSIFIED SECTION

    Follow Directions on Back Panel

    Bloat Guard® is a Phibro Animal Health registered trademark for Poloxalene

    Phibro Animal Health, Teaneck, NJ 07666.

    Verxite® is a registered trademark of

    W.R. Grace & Company.

    6080000

    101-9030-07

  • PRINCIPAL DISPLAY PANEL

    Bloat Guard Top Feed Product Label
  • INGREDIENTS AND APPEARANCE
    BLOAT GUARD 
    poloxalene powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:66104-6080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLOXALENE (UNII: V8B3K56SW0) (POLOXALENE - UNII:V8B3K56SW0) POLOXALENE240.4 g  in 0.45 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66104-6080-09.08 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03270403/10/1966
    Labeler - Phibro Animal Health (006989008)
    Registrant - Phibro Animal Health (006989008)