FDA.reportPublic FDA data

Bloat Guard

Manufacturer
Phibro Animal Health
Effective date
2019-06-27
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:40:27

Label at a glance#

ProductBloat Guard
Active ingredientPOLOXALENE
Label structure8 sections

Dosage and administration

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 Bloa...

Storage and handling

 

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

For use in the manufacture of feed

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

Active Ingredient

DESCRIPTION SECTION

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

(Equivalent to 240 g/lb)

Inert Ingredients:

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

CAUTION:

WARNINGS AND PRECAUTIONS SECTION

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

STORAGE AND HANDLING SECTION

 

Mixing Directions

DOSAGE & ADMINISTRATION SECTION

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.

Warning:

WARNINGS SECTION

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

8818000

101-9029-09

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BloatGuard Prx - 09
BloatGuard Prx - 09

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66104-2301-0Bloat Guard22.7 kg in 1 BAGPOWDER22.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66104-2301BLOAT GUARD (POLOXALENE) POWDER [PHIBRO ANIMAL HEALTH]31 package rows20190629_b1ac0728-ab91-4eb6-9e19-3f84a7f58d7d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLOXALENEACTIVE INGREDIENTV8B3K56SW01
POLOXALENEACTIVE MOIETYV8B3K56SW01
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
ETHOXYQUININACTIVE INGREDIENT9T1410R4OR1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66104-230166104-2301-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLOXALENEV8B3K56SW0ACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ETHOXYQUIN9T1410R4ORIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / SUBLINGUAL0.13 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.