INSTAMIX GLYCOLIC CONCENTRATE- glycerin, glycolic acid concentrate

InstaMix Glycolic Concentrate by

Drug Labeling and Warnings

InstaMix Glycolic Concentrate by is a Animal medication manufactured, distributed, or labeled by DeLaval, WestAgro, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

A glycolic concentrate designed for use with InstaMixTM G Emollient Concentrate using a DeLaval recommended on-site blending unit.

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Glycolic Acid ................... 15% 

Emollient* ...................... 10%

*from Glycerin

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

! CAUTION

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READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

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InstaMixTM Glycolic Concentrate (Part A) is a glycolic concentrate exclusively designed for use in combination with InstaMixTM G Emollient Concentrate (Part B) for on-site blending/production of teat dips.  To be blended with a DeLaval recommended on-site blending unit.

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FIRST AID

Immediately call a poison control center or doctor/physician

Eye contact: Rinse cautiously with water for several minutes.  Remove contact lenses, if present and easy to do.  Continue rinsing.  Immediately call a poison control center or doctor/physician.

If on Skin:  Remove/Take off immediately all contaminated clothing.  Rinse skin with water/shower.  Wash contaminated clothing before reuse.

If Inhaled:  Remove victim to fresh air and keep at rest in a position comfortable for breathing.  Immediately call a poison control center or doctor/physician.

If swallowed:  Rinse mouth.  Do not induce vomiting.

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 from freezing.  If product is frozen, thaw in warm room and mix well before using. Store in a cool, dry space.  Keep container tightly closed when not in use.  Do not reuse empty container.  Dispose of contents/container to an approved waste disposal plant.

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CHEMTREC EMERGENCY NUMBER 1-800-424-9300

WARNINGS AND PRECAUTIONS

Not For Human Use

Additional Information on Safety Data Sheet

INDICATIONS & USAGE

GENERAL INSTRUCTIONS

• Do not use full-strength.
• Consult veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped.
• Do not use teat dip for cleaning and/or sanitizing of dairy equpment.
• Discard any teat sanitizing 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 the control of mastitis.
• To be mixed with InstaMixTM G Emollient Concentrate (Part B) using a DeLaval recommended on-site blending unit.  Can be diluted to create 6 formula options

USE DIRECTIONS

Pre-Dipping

• Remove excess organic debris and forestrip.
• Dip or spray cow's teats with properly diluted teat dip prepared with a DeLaval recommended on-site blending unit.
• Allow a 30 second contact time.
• Dry teats thoroughly with a clean, single-service paper towel.
• Attach milker unit.

Post-Dipping

• Immediately after removing the milker unit, dip or spray each teat with properly diluted teat dip prepared with a DeLaval recommended on-site blending unit.
• Before exposing cow's teats to below freezing temperatures, the teats should be thoroughly dry to reduce the potential of frostbite.  Failure to follow these instructions may result in frozen teats and injured animals.

 Setting on InstaMixTM

InstamixTM Formula	% Glycolic Acid	% Emollient
Glycolic 3%-2%	3	2
Glycolic 3%-5%	3	5
Glycolic 3%-10%	3	10
Glycolic 3%-20%	3	20
Glycolic 3%-30%	3	30
Glycolic 3%-40%	3	40

USER SAFETY WARNINGS

UN3265

Corrosive Liquid, Acidic, Organic, N.O.S. (Glycolic Acid)

WARNINGS

HAZARD STATEMENTS

Causes severe skin burns and eye damage.  Do not breathe dust/fume/gas/mist/vapors/spray.  Wash face, hands and any exposed skin thoroughly after handling.  Wear protective gloves/protective clothing/eye protection/face protection.

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NET CONTENTS:

LOT NO.:

EXP. DATE:

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

INSTAMIX GLYCOLIC CONCENTRATE 
glycerin, glycolic acid concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 55756-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S)	GLYCOLIC ACID	150 g  in 1 L
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	100 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CAPRYLYL SULFONATE (UNII: J46EZ5JYB3)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
C9-11 PARETH-8 (UNII: 80E6PSE1XL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55756-157-01	208 L in 1 DRUM
2	NDC: 55756-157-27	1041 L in 1 TANK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/06/2021

Labeler - DeLaval (173704867)

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

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

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