1. Home
  2. Animal Drug Index - B
  3. Bloat Guard

Animal NDC 66104-6080-0 Bloat Guard

Poloxalene

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-6080-0
Proprietary Name Bloat Guard What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Poloxalene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Phibro Animal Health
Product Type Otc Type A Medicated Article Animal Drug
Usage Information
    Bloat Guard is to be consumed daily. Bloat Guard should be sprinkled on individual rations of ground feed, starting 2 or 3 days before animals are exposed to bloat-producing conditions. 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 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, sprinkle Bloat Guard on top of the feed.Caution: It is essential that each animal consumes the total recommended dosage of Bloat Guard daily for adequate protection.
Active Ingredient(s)
  • Poloxalene
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA032704 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Bloat Guard Images

Bloat Guard Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Medicated Top Dressing for Feed

Indications for Use:

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

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

Store At or Below 25°C (77°F), Excursions Permitted Up To 40°C (104°F)

NOT FOR HUMAN USE

Restricted Drug (California) – Use Only As Directed

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

Distributed by:

Phibro Animal Health Corporation, Teaneck, NJ 07666.

6080000

101-9030-09


Active Ingredient



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


Inert Ingredient:



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


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.

Follow Directions on Back Panel

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

Phibro Animal Health Corporation, Teaneck, NJ 07666.

Approved by FDA under NADA #032-704

6080000

101-9030-09


Directions For Use The Dose Of Bloat Guard Is Proportional To Body Weight And Also Depends Upon The Severity Of The Bloat-Producing Conditions. The Dose Of 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 Dose Should Be Doubled (2 G Of Poloxalene Per 100 Lb Of Body Weight).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 Doseanimal Weightnumber Of Measuresdose (Grams)500½ To 15 To 1010001 To 210 To 2015001 ½ To 315 To 3020002 To 420 To 40



Bloat Guard is to be consumed daily. Bloat Guard should be sprinkled on individual rations of ground feed, starting 2 or 3 days before animals are exposed to bloat-producing conditions.

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 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, sprinkle Bloat Guard on top of the feed.

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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.