Label: BLOAT GUARD- poloxalene powder
- NDC Code(s): 66104-2301-0
- Packager: Phibro Animal Health
- Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated June 27, 2019
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- INDICATIONS & USAGE
- Active Ingredient
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
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
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).
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.
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
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)
Approved by FDA under NADA #032-704
Verxite® is a registered trademark of W.R. Grace & Company
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:66104-2301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLOXALENE (UNII: V8B3K56SW0) (POLOXALENE - UNII:V8B3K56SW0) POLOXALENE 240 g in 0.45 kg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ETHOXYQUIN (UNII: 9T1410R4OR) 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) Registrant - Phibro Animal Health (006989008)