DELLA BARRIER 2500- iodine solution

Della Barrier 2500 by

Drug Labeling and Warnings

Della Barrier 2500 by is a Animal medication manufactured, distributed, or labeled by DeLaval, WestAgro, Inc., K Klean dba WestArgo, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

0.25% Iodine* Barrier Teat Dip with 5.00% Emolient

Contiene 0.25% de yodo y 5.00% de emolientes

ACTIVE INGREDIENTS:

Iodine*.......................0.25%

*From polyethoxy polypropoxy polyethoxy ethanol-iodine complex

Emollient**.................5.0%

**From glycerine and sorbitol

SPL UNCLASSIFIED SECTION

I2

BARRIER TECHNOLOGY

NPE FREE Formula

I-tech

FREE IODINE TECHNOLOGY

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

! CAUTION

MANTENER FUERA DEL ALCANCE DE LOS NIÑOS

! CUIDADO

SPL UNCLASSIFIED SECTION

SI USTED NO PUEDE LEER ESTA ETIQUETA, POR FAVOR PIDA A ALGUIEN MAS QUE SE LA LEA ANTES DE USAR ESTE PRODUCTO

READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

SPL UNCLASSIFIED SECTION

FIRST AID

Contact with product can cause irritation to eyes.  Avoid contact with eyes.

If in Eyes:  Flush with water.  Remove contact lenses, if present, after first 5 minutes.  Then continue rinsing.  Get immedicate medical attention.

If Swallowed:  Do not induce vomiting.  If victim is fully conscious, give a cupful of water.  Never give anything by mouth to an unconscious person.  Get immediate medical attention.

STORAGE AND HANDLING

STORAGE AND DISPOSAL

THOROUGHLY RINSE ALL MEASURING DEVICES AND STORE OUT OF REACH OF CHILDREN.  Avoid contact with food or feed.  Avoid storing near heat or open flame.  Keep container tightly closed when not in use.  If product has frozen, thaw in a warm room and shake well before use.  Do not reuse empty container.  Rinse empty container before disposing of in a safe manner.  Do not store in direct sunlight.

SPL UNCLASSIFIED SECTION

CHEM-TREC EMERGENCY NUMBER 1-800-424-9300

WARNINGS

Not For Human Use

Additional Information on Safety Data Sheet

INDICATIONS & USAGE

GENERAL INSTRUCTIONS

• Use Della Barrier 2500TM teat sanitizer undiluted.
• Consult veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped.
• Store at room temperature.
• Do not use teat sanitizer for cleaning or sanitizing dairy equipment.
• Discard any teat sanitizer solution that becomes dirty or contaminated for any reason.
• Good dairy practices suggest the thorough cleaning and sanitizing of teats before milking to avoid contamination and assist in control of mastitis.

POST-DIPPING

• Immediately after removing milker unit, dip each teat with Della Barrier 2500TM
• Allow Della Barrier 2500TM to air dry.  Do not wipe off.
• Do not expose teats to freezing conditions until they are dry.  

SPL UNCLASSIFIED SECTION

Manufactured for:  DeLaval, Inc.

11100 N. Congress Avenue

Kansas City, MO 64153

Phone: 816-891-7700

Manufactured by:  WestAgro, Inc.

©2020. Made in USA

NET CONTENTS:

LOT NO.:

EXP. DATE:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DELLA BARRIER 2500 
iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 55756-336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	.0025 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
POVIDONE K30 (UNII: U725QWY32X)
POLOXAMER 335 (UNII: G6DQL26D50)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM IODATE (UNII: U558PCS5Z9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55756-336-02	56.8 L in 1 PAIL
2	NDC: 55756-336-01	208.2 L in 1 DRUM
3	NDC: 55756-336-27	1041 L in 1 TANK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/11/2020

Labeler - DeLaval (173704867)

Establishment
Name	Address	ID/FEI	Business Operations
WestAgro, Inc.		147528723	manufacture, label, pack, api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
K Klean dba WestAgro, Inc.		002222368	manufacture, label, pack, api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
WestAgro, Inc.		095906480	manufacture, label, pack, api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
WestAgro, Inc.		069288728	api manufacture, manufacture, pack, label