Label: BLOAT GUARD- poloxalene powder 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/09

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

  • INDICATIONS & USAGE

    For use in the manufacture of feed

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

    Close
  • Active Ingredient

    Poloxalene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53%

    (Equivalent to 240 g/lb)

    Inert Ingredients:

    Ethoxyquin (a preservative), 0.064%; butylated hydroxytoluene (a preservative), 0.20%; Verxite ® (nonnutritive), approximately 47%

    Close
  • 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.

    Close
  • STORE AT ROOM TEMPERATURE

     

    Close
  • Mixing Directions

    Bloat Guard Type A Medicated Article must be thoroughly and evenly distributed into feedstuffs. A mixture of Bloat Guard and 1 common feed ingredient should be made before final mixing when less than 25 lb of Bloat Guard is to be blended into a ton of feed.

    Possible Mixing Ratios

    Each lb of Bloat Guard contains 240 g of poloxalene, the active drug ingredient. The following table illustrates various amounts of Bloat Guard which may be added to feeds. The resulting concentration of poloxalene is also shown.

    lb of Bloat Guard per ton of Type C Medicated Feed

    g of poloxalene per lb of Type C Medicated Feed

    % w/w of poloxalene in Type C Medicated Feed

    8.3 lb

    16.6 lb

    33.2 lb

    50.0 lb

    83.3 lb

    100.0 lb

    208.3 lb

    416.6 lb

    625.0 lb

    833.3 lb

    1

    2

    4

    6

    10

    12

    25

    50

    75

    100

    0.22

    0.44

    0.88

    1.32

    2.20

    2.64

    5.50

    11.00

    16.50

    22.00

    For example: 50 lb of Bloat Guard, when added to 1 ton of feed, results in a final concentration of 6 g poloxalene per lb of Type C Medicated Feed (1.32% by weight).

    Feeding Directions

    The dosage of Bloat Guard is proportional to body weight and also depends upon the severity of the bloat-producing conditions. The normal dosage of Bloat Guard (1 g of poloxalene per 100 lb of body weight) is recommended for cattle under moderate bloat-producing conditions. For cattle under severe bloat-producing conditions, the normal dosage should be doubled (2 g of poloxalene per 100 lb of body weight).

    Repeat the feeding of Bloat Guard when animals are exposed to bloat-producing conditions more than 12 hours from the last feeding of Bloat Guard, but do not exceed the double dosage of Bloat Guard in any 24-hour period. Animals should be fed the recommended amounts of Bloat Guard starting 2 or 3 days before they are exposed to bloat-producing conditions.

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

    Close
  • 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

    RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

    Close
  • SPL UNCLASSIFIED SECTION

    Follow Directions on Back Panel

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

    Phibro Animal Health, Inc., Ridgefield Park, NJ 07660.

    Net Weight 50 lb (22.7 kg)

    NADA #32-704, Approved by FDA

    8818000

    101-9029-05

    Verxite® is a registered trademark of W.R. Grace & Company

    Close
  • INGREDIENTS AND APPEARANCE
    BLOAT GUARD 
    poloxalene powder
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:66104-2301
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLOXALENE (POLOXALENE) POLOXALENE 240 g  in 0.45 kg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE  
    ETHOXYQUIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66104-2301-0 22.7 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA032704 03/10/1966
    Labeler - Phibro Animal Health (006989008)
    Close