Animal NDC 54771-1461-1 Bovatec
Lasalocid Sodium
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 54771-1461-1 |
| Proprietary Name | Bovatec 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 | Lasalocid Sodium 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 | Zoetis Inc. |
| Product Type | Otc Type A Medicated Article Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| 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 | NADA096298 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. |
Bovatec 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
Active Ingredient
Each pound contains 90.7 grams (20%) of lasalocid (as lasalocid sodium activity) in a carrier suitable for incorporation in feed.
Important
Handling Information - Must be thoroughly mixed in feeds before use. When mixing and handling lasalocid Type A medicated articles, use protective clothing, impervious gloves and a dust mask. Avoid contact with eyes. Operators should wash hands thoroughly with soap and water after handling.
Mixing Directions
This product should be further diluted in an intermediate blending step prior to mixing in the final feed. Do not feed undiluted.
1. Complete Feed
a. Intermediate blending: Mix 1 part of Bovatec 91 (Type A Medicated Article) with 17 parts of finely ground non-medicated feedstuffs to provide an intermediate preblend containing 5 grams of lasalocid per pound.
b. Using the 5 g/lb intermediate preblend, the following table would apply to the manufacture of complete feeds:
| Intended lasalocid concentration in the complete feed | Add the following amounts of 5 grams per pound intermediate preblend per ton of complete feed mixed: | |
|---|---|---|
| grams/ton | mg/lb | lbs/ton |
| 10 | 5 | 2 |
| 15 | 7.5 | 3 |
| 30* | 15 | 6 |
* Maximum approved concentration for complete feeds for cattle fed in confinement for slaughter and sheep in confinement
c. Using the 5 g/lb intermediate preblend, the following table would apply to the manufacture of other complete feeds and supplements that do not require further mixing:
| Daily feeding rate | Desired daily lasalocid intake | Add the following amounts of 5 grams per pound intermediate preblend per ton of feed or supplement mixed: | Lasalocid will be present in the feed or supplement at the following concentration: |
|---|---|---|---|
| lbs/head/day | mg/head/day | lbs/ton | grams/ton |
| 1 | 60 | 24 | 120 |
| 200 | 80 | 400 | |
| 300 | 120 | 600 | |
| 2 | 60 | 12 | 60 |
| 200 | 40 | 200 | |
| 300 | 60 | 300 | |
| 3 | 60 | 8 | 40 |
| 200 | 26.7 | 133.5 | |
| 300 | 40 | 200 |
2. Dry Supplement
a. Intermediate blending: Mix 1 part Bovatec 91 Type A Medicated Article with 3.5 parts of finely ground non-medicated feedstuffs to provide an intermediate preblend containing 20 grams of lasalocid per pound. For example, mix one 50 lb bag of Bovatec 91 Type A Medicated Article with 175 lbs of non-medicated feedstuffs.
b. Using the 20 g/lb intermediate preblend, the following table would apply to the manufacture of dry supplements:
| Intended lasalocid concentration in the supplement | Add the following amounts of 20 grams per pound intermediate preblend per ton of supplement mixed: | |
|---|---|---|
| grams/ton | mg/lb | lbs/ton |
| 400 | 200 | 20 |
| 600 | 300 | 30 |
| 1000 | 500 | 50 |
| 1440 | 720 | 72 |
| 1600 | 800 | 80 |
c. Thoroughly mix supplement with sufficient non-medicated feedstuffs in accordance with the feeding rates listed in the use directions below.
3. Liquid Supplement Intended for Addition to Dry Feeds
a. Supplements with suspending agent(s) should be in a pH range of 4-8 and maintain physical stability for up to three months with a viscosity not less than 300 cps.
b. Conventional liquid supplements should be in a pH range of 4-8.
For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
Use Directions
| Species | Dose | Indications for use |
|---|---|---|
| Cattle Fed in Confinement for Slaughter | 10-30 grams lasalocid per ton of total ration (90% dry matter) | For improved feed efficiency in cattle fed in confinement for slaughter, feed continuously to provide not less than 100 mg nor more than 360 mg per head per day. |
| 25-30 grams lasalocid per ton of total ration (90% dry matter) | For improved feed efficiency and increased rate of weight gain in cattle fed in confinement for slaughter, feed continuously to provide not less than 250 mg nor more than 360 mg per head per day. | |
| Pasture Cattle – slaughter, stocker, feeder cattle, and dairy and beef replacement heifers | 60-300 mg lasalocid per head/day | For increased rate of weight gain. The drug must be contained in at least 1 pound of feed and fed continuously on a daily basis. |
| 60-300 mg lasalocid per head/day | For increased rate of weight gain, feed continuously on a free-choice basis. A medicated feed mill license is required when free-choice feed is manufactured using a proprietary formula and/or specifications. Free-choice feed formulations must be FDA-approved. | |
| Daily lasalocid intakes in excess of 200 mg per head per day have not been shown to be more effective than 200 mg lasalocid per head per day. | ||
| NOTE: Coccidiosis may occur when young pasture cattle are co-mingled with adult cattle passing coccidial oocysts. | ||
| Cattle | 1 mg lasalocid per 2.2 lbs body weight/day | For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs. Hand feed continuously to provide not more than 360 mg per day. |
| Sheep | 20-30 grams lasalocid per ton of total ration (90% dry matter) | For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, and E. intricata in sheep maintained in confinement. Feed continuously to provide not less than 15 mg nor more than 70 mg per head per day depending on body weight. |
Caution
Animal Safety - Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.
Withdrawal Periods And Residue Warnings
No withdrawal period is required when used according to labeling.
A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in calves to be processed for veal.
Principal Display Panel - 50 Lb Label
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.