Terramycin 100

Manufacturer: Phibro Animal Health
Effective date: 2023-07-19
Label type: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 02:42:09

Label at a glance#

ProductTerramycin 100

Active ingredientOXYTETRACYCLINE HYDROCHLORIDE

Label structure5 sections

Storage and handling

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS, USE DIRECTIONS, AND WARNINGS Terramycin is a registered trademark of Pfizer, Inc., licensed to Phibro Animal Health Corporation, for Oxytetracycline PHIBRO and PHIBRO logo design are trademarks owned by Phibro Animal Health Corporation or its affiliates Phibro Animal Health Corporation, Teaneck, NJ 07666 Net Weight 50 lb (22.7 kg) Approved by FDA under NADA # 095-143 ...

Label contents#

Full prescribing information#

Active Drug Ingredient:

DESCRIPTION SECTION

Oxytetracycline (from oxytetracycline dihydrate base) equivalent to

oxytetracycline 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.

CAUTION: 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 Or Below 25°C (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)

STORAGE AND HANDLING SECTION

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,

USE DIRECTIONS, AND WARNINGS

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health Corporation, for Oxytetracycline

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation or its affiliates

Phibro Animal Health Corporation, Teaneck, NJ 07666

Net Weight 50 lb (22.7 kg)

Approved by FDA under NADA # 095-143

8844000

101-9008-10

FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

DOSAGE & ADMINISTRATION SECTION

Mixing and Use Directions

Thoroughly mix the amount of this Type A medicated article according to the directions below with at least an equal amount by weight of feed formula ingredients prior to blending into a complete feed.

Indications for Use	Oxytetracycline Amount	lb of Terramycin 100/ton
CHICKENS
Control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline	100-200 g/ton Feed continuously for 7-14 days	1-2
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline	400 g/ton Feed continuously for 7-14 days	4
Reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline	500 g/ton Feed continuously for 5 days	5
WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Zero-day withdrawal period for lower use levels. Do not use in low-calcium feed containing less than 0.55 dietary calcium. Use in such may result in violative residues. Do not administer to chickens producing eggs for human consumption.
TURKEYS
Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline	100 g/ton Feed continuously for 7-14 days	1
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline	200 g/ton Feed continuously for 7-14 days	2
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline	25 mg/lb of body weight daily Feed continuously for 7-14 days	8.3¹
WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption.
SWINE
Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for 7-14 days	5²
For breeding swine for control and treatment of Leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for not more than 14 days	5²
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE
For growing cattle (over 400 lb) for the reduction of the incidence of liver abscesses	75 mg/head/day Feed continuously	0.75³
Prevention and treatment of the early stages of shipping fever complex (Feed 3-5 days before and after arrival in feedlots.)	0.5-2.0 g/head/day	5-20³
Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for 7-14 days	50⁴
SHEEP
Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for 7-14 days	12⁵
WARNING: 5-day withdrawal before slaughter.
¹If bird weighs 10 lb, consuming 0.6 lb of complete feed per day ²Pig consuming 4 lb of complete feed per 100 lb body weight per day ³Include in feed supplement based on consumption of 2 lb of supplement per head per day ⁴If animal weighs 500 lb, consuming 2 lb of supplement per head per day ⁵If lamb weighs 60 lb, consuming 1 b of supplement per head per day

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

NOT FOR HUMAN USE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Terramycin 100Terramycin 100

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66104-7100-0	Terramycin 100	22.7 kg in 1 BAG	POWDER	22.7		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66104-7100	TERRAMYCIN 100 (OXYTETRACYCLINE) POWDER [PHIBRO ANIMAL HEALTH]	10	1 package rows	20230720_97bfb783-071a-48d4-9d78-76ea2d4024f4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OXYTETRACYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	4U7K4N52ZM	4
OXYTETRACYCLINE ANHYDROUS	ACTIVE MOIETY	SLF0D9077S	4
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	4
RICE BRAN	INACTIVE INGREDIENT	R60QEP13IC	4

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Terramycin 100
oxytetracycline
OXYTETRACYCLINE HYDROCHLORIDE
OXYTETRACYCLINE ANHYDROUS
MINERAL OIL
CALCIUM CARBONATE
RICE BRAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66104-7100	66104-7100-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OXYTETRACYCLINE HYDROCHLORIDE	4U7K4N52ZM	ACTIB
MINERAL OIL	T5L8T28FGP	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
RICE BRAN	R60QEP13IC	IACT

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 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, CHEWABLE / ORAL		1650 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	GUM, CHEWING / BUCCAL		3492 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / AURICULAR (OTIC)	0.38 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, DELAYED RELEASE / ORAL	8.4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE / ORAL	349.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / RESPIRATORY (INHALATION)	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, FILM COATED / ORAL		300 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, EXTENDED RELEASE / ORAL	229.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	FILM, SOLUBLE / ORAL		14 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / INTRAVENOUS	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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