Animal NDC 66104-0006-4 Mecadox
Carbadox

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-0006-4
Proprietary Name Mecadox 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 Carbadox 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
    Control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency in swine.
Active Ingredient(s)
  • Carbadox
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM PROPIONATE (8AI80040KW)
  • SOYBEAN (L7HT8F1ZOD)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM PROPIONATE (8AI80040KW)
  • SOYBEAN (L7HT8F1ZOD)
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 NADA041061 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.

Mecadox Images

Mecadox 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 Drug Ingredient:



Carbadox . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2% (10 g/lb)


Indications For Use:



Control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency in swine.


Warning:



For use in the manufacture of complete swine feeds and/or swine protein supplement feeds only.

Do not feed to swine within 42 days before slaughter.

Caution: Not for use in pregnant swine or swine intended for breeding purposes.

Do not mix in feeds containing bentonite.

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED


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.


Complete Swine Feed



Mixing and Use Directions

Indications for Use

Amount of Drug

lb of Mecadox® 10 per ton of Complete Feed

Increased rate of weight gain and improved feed efficiency

0.0011-0.00275%

(10-25 g/ton)

1.0-2.5 lb

Control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency.

0.0055%

(50 g/ton)

5.0 lb

Protein Supplement

Mixing and Use Directions

Amount of Supplement per Ton of Complete Feed (lb)

lb of Mecadox® 10 per Ton of Protein Supplement

Desired Level of Mecadox® in Complete Feed

0.0055%

(50 g/ton)

0.00275%

(25 g/ton)

0.0011%

(10 g/ton)

1000

667

500

250

100

75

50

40

20

10

15

20

40

100

133

200

250

500

5

7

10

20

50

67

100

125

250

2

3

4

8

20

27

40

50

100


Storage And Handling



Store At Or Below 25oC (77oF), Excursions Permitted Up To 40oC (104oF)


Other



See Back PANEL for Further Use Directions

Mecadox® is a Phibro Animal Health Corporation registered trademark for Carbadox

Phibro Animal Health Corporation, Teaneck, NJ 07666.

Net Weight 40 lb (18.2 kg)

7913000

101-9383-01

Approved by FDA under NADA # 041-061


Mecadox 10



Mecadox 10


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