AMPROLIUM by Phibro Animal Health Ltd. / Phibro Animal Health / PHIBRO ANIMAL HEALTH LTD AMPROLIUM powder

AMPROLIUM by

Drug Labeling and Warnings

AMPROLIUM by is a Other medication manufactured, distributed, or labeled by Phibro Animal Health Ltd., Phibro Animal Health, PHIBRO ANIMAL HEALTH LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Package Label/Prinicipal Display Panel

For the manufacture of veterinary pharmaceutical products only.
1-[(4-Amino-2-Propyl-5-Pyrimidinyl) Methyl]-2-Methylpyridinium Chloride Hydrochloride

WARNINGS AND PRECAUTIONS

Note: Keep container tightly closed.
Note: For additional information, see Material Safety Data Sheets for this material.

FIRST AID MEASURES

Eye contact: Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids.
Consult a physician.
Inhalation: Remove to fresh air.
Skin contact: Wash off immediately with soap and plenty of water while removing all contaminated
clothes and shoes.
Ingestion: Consult a physician if necessary.
Self-protection of the first aider: use personal protective equipment as required.

STORAGE CONDITIONS

Keep container tightly closed in a dry and well-ventilated place.
Store in accordance with local regulations. Keep/store only in original container.
Store between 5°C and 25°C, excursion permitted up to 40°C.

SPL UNCLASSIFIED SECTION

Lot:

Manuf. Date:

Retest Date:

Net Weight 25kg

SPL UNCLASSIFIED SECTION

Product license holder:
Phibro Animal Health Corporation, Glenpointe Centre East,
3rd FL
300 Frank W. Burr Blvd, Ste 21,
Teaneck, NJ 07666
United states of America

Manufacturing site:
Phibro Animal Health Corporation
601 Beam St, Salisbury, Maryland 21801
United States of America

FEI Number: 1150033
NDC# 54277-0022-1

101-8305-01

Label

Amprolium Label

INGREDIENTS AND APPEARANCE

AMPROLIUM 
amprolium powder

Product Information
Product Type		Item Code (Source)	NDC: 54277-0022
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM - UNII:95CO6N199Q)	AMPROLIUM	1 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54277-0022-1	25 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Bulk ingredient		06/27/1990

Labeler - Phibro Animal Health Ltd. (600016711)

Registrant - Phibro Animal Health (006989008)

Establishment
Name	Address	ID/FEI	Business Operations
PHIBRO ANIMAL HEALTH LTD		600016711	api manufacture, analysis