CLTC 100 MR

Manufacturer
Phibro Animal Health
Effective date
2023-07-20
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:42:09

Label at a glance#

ProductCLTC 100 MR
Active ingredientCHLORTETRACYCLINE HYDROCHLORIDE
Label structure6 sections

Dosage and administration

For premix quantities less than 1 lb. Mix the proper amount of premix with at least 10 lb of feed ingredients to make a preblend. Add the preblend to the remaining feed ingredients and mix thoroughly. Indications for Use Use Level of CLTC lb of CLTC 100 MR/ton CALVES–Milk Replacers or Starter Feeds For calves (up to 250 lb) for the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline...

Label contents#

Full prescribing information#

Active Drug Ingredient:

DESCRIPTION SECTION

Chlortetracycline hydrochloride . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb

CAUTION:

WARNINGS AND PRECAUTIONS SECTION

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

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.

Directions for Use

DOSAGE & ADMINISTRATION SECTION

For premix quantities less than 1 lb. Mix the proper amount of premix with at least 10 lb of feed ingredients to make a preblend. Add the preblend to the remaining feed ingredients and mix thoroughly.

Indications for Use

Use Level of CLTC

lb of CLTC 100 MR/ton

CALVES–Milk Replacers or Starter Feeds For calves (up to 250 lb) for the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline.

10 mg/lb

body weight daily

Limit use to 5 days

201

WARNING: At 10 mg/lb use level, withdraw 10 days before slaughter. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.

1 Calf weighing 100 lb consuming 1 lb of dry starter feed or 1 lb of milk replacer mixed with one gallon of water.

INDICATIONS & USAGE SECTION

FOR USE IN DRY FEEDS ONLY.

NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

NOT FOR HUMAN USE.

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED.

SPL UNCLASSIFIED SECTION

CLTC® is a registered trademark of Phibro Animal Health Corporation for chlortetracycline.

Phibro Animal Health Corporation, Teaneck, NJ 07660.

Net Weight 50 lb (22.7 kg)

Approved by FDA under NADA # 092-287

101-8033-08

Prinicipal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLTC 100 Label
CLTC 100 Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66104-6300-0CLTC 100 MR22.7 kg in 1 BAGPOWDER22.79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66104-6300CLTC 100 MR (CHLORTETRACYCLINE HYDROCHLORIDE) POWDER [PHIBRO ANIMAL HEALTH]91 package rows20230721_f65a7756-a03e-481e-943b-fdc6c715a454.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORTETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTO1GX33ON8R5
CHLORTETRACYCLINEACTIVE MOIETYWCK1KIQ23Q5
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W25

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
66104-630066104-6300-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

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 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2PASTILLE / ORAL826 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER / VAGINAL430 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET / ORAL183.66 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET / SUBLINGUAL115.78 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRAVENOUS51.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRASPINAL75 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, EXTENDED RELEASE / ORAL103.95 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2LOZENGE / BUCCALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SYRUP / ORAL620 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TROCHE / ORAL903.5 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, COATED / ORAL132 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2CONCENTRATE / ORAL400 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRATHECAL1925 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SOLUTION / INTRAVENOUS5.05 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SOLUTION / ORAL2489 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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