DURA - GUARD- iodine liquid

DURA - GUARD by

Drug Labeling and Warnings

DURA - GUARD by is a Animal medication manufactured, distributed, or labeled by IBA, Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:

Iodine ........................................................................1.00%

(Provide 1.0% minimum Titratable Iodine)

INERT INGREDIENTS:

Glycerin.......................................................................2.00%

Other Inerts................................................................97.00%

(Includes Buffering Agents, Stabilizing Agents and Surfactants)

TOTAL:.....................................................................100.00%

               This product contains highly effective levels of

              Free iodine for fast kill of mastitis causing organisms.

GENERAL PRECAUTIONS

GENERAL RECOMMENDATIONS

1. Use teat dip applicators made of plastic or other non-corrosive materials. Do not use cups made of aluminum.

2. When solution in the teat dip cup becomes dirty and/or noticeably loses color, discard remaining contents and refill cup with fresh teat dip.

3. Do not use this product for cleaning or sanitizing equipment.

4. Wash teat dip cups after each milking.

INDICATIONS & USAGE

RECOMMENDED PROCEDURES FOR TEAT SANITATION

POST-MILKING (POST-DIPPING)

Immediately after milking, dip all teats full length with DURA-GUARD Teat Dip.

Ensure good coverage of all sides of the teats and teat orifices.

WARNINGS

WARNING

DO NOT DILUTE THIS PRODUCT.

DO NOT RETURN TEAT DIP LEFT IN THE TEAT DIPPER TO STORAGE CONTAINER.

ENSURE THAT DIPPED TEATS ARE DRY BEFORE EXPOSING THE ANIMALS TO WEATHER CONDITIONS WHICH MAY CAUSE DAMAGE TO THE TEATS.

PROTECT THIS PRODUCT FROM FREEZING.

CAUTION: KEEP OUT OF REACH OF CHILDREN

AVOID CONTACT WITH FOOD. DO NOT TAKE INTERNALLY.

OTHER SAFETY INFORMATION

FIRST AID PROCEDURES

EYE CONTACT: IMMEDIATELY FLUSH EYE WITH LARGE AMOUNTS OF FRESH, TEPID WATER FOR 15 MINUTES. HOLD EYELID OPEN TO ENSURE COMPLETE IRRIGATION OF EYE AND LID TISSUES. TILT HEAD TO THE SIDE AND IRRIGATE THE EYE FROM THE BRIDGE OF THE NOSE TO THE OUTSIDE OF THE FACE.

SKIN CONTACT: WASH ANY SENSITIVE AREAS.

INGESTION: DO NOT INDUCE VOMITING. NEVER GIVE ANYTHING BY MOUTH TO AN UNCONSCIOUS PERSON. DRINK LARGE AMOUNTS OF WATER. IF VOMITING OCCURS KEEP AIRWAYS OPEN. KEEP HEAD LOWER THAN THE HIPS TO PREVENT ASPIRATION INTO THE LUNGS.

                                                             ALWAYS SEEK IMMEDIATE MEDICAL ATTENTION

                                                           FOR MEDICAL EMERGENCIES CALL 1-800-424-9300

SANITIZING 1% IODINE BARRIER TEAT DIPA "TRUE" BARRIER TEAT DIP CONTAINING GLYCERINPROTECTS AGAINST BOTH CONTAGIOUS & ENVIRONMENTAL BACTERIAESPECIALLY FORMULATED FOR DAIRIES WHERE NPE FREE TEAT DIPS ARE PREFERRED OR REQUIRED

Dura-Guard

INGREDIENTS AND APPEARANCE

DURA - GUARD 
iodine liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 29983-1060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	1.0 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29983-1060-4	19.20 kg in 1 PAIL
2	NDC: 29983-1060-6	57.62 kg in 1 DRUM
3	NDC: 29983-1060-8	211.30 kg in 1 DRUM
4	NDC: 29983-1060-9	1056.52 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2015

Labeler - IBA (019494160)

Registrant - IBA (019494160)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture, api manufacture, pack