Label: INSTAMIX EMOLLIENT CONCENTRATE EC- glycerine concentrate
- NDC Code(s): 55756-352-01, 55756-352-27
- Packager: DeLaval Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 11, 2022
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- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- WARNINGS AND PRECAUTIONS
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INDICATIONS & USAGE
InstaMix™ Emollient Concentrate EC (Part B) is an emollient concentrate exclusively designed for use in combination with InstaMix™ Iodine Concentrate IC (Part A)and CD X-10 Pre-Post Activator and Base for on-site blending / production of teat dips. To be blended with a DeLaval recommended on-site blending unit.
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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.
- Keep container tightly closed when not in use.
- Do not reuse empty container.
- Rinse empty container before disposing in a safe manner.
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INSTRUCTIONS FOR USE
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 equipment.
- 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 Iodine Concentrate IC (Part A) or CD X-10 Pre-Post Activator and Base using a DeLaval recommended on-site blending unit.
DILUTIONS
When blending the emollient concentrate with InstaMix™ Iodine Concentrate IC (Part A), choose one of the following combinations of iodine and emollient:
% Iodine: 0.25, 0.5, 0.75, 1.0
% emollient: 2.0, 3.5, 5.0, 10.0, 12.0, 14.0, 15.0, 20.0
IMPORTANT!
- 0.25% teat dip must be mixed on demand.
- 0.5% - 10% teat dip must be used within two weeks after mixing.
- Discard unused mixtures after above noted times.
When blending the emollient concentrate to generate chlorine dioxide with CD X-10 Pre-Post Activator and Base, must stay within the following ranges:
IMPORTANT! This is a two-part concentrate - must be mixed prior to use
Target chlorine dioxide with sodium chlorite: 800 to 1200 ppm
Target % emollient range: 0.5, 1.0, 3.0, 4.0, 5.0
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.
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INSTAMIX EMOLLIENT CONCENTRATE EC
glycerine concentrateProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55756-352 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 500 g in 1 L Inactive Ingredients Ingredient Name Strength IODINE (UNII: 9679TC07X4) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55756-352-01 208.4 L in 1 DRUM 2 NDC:55756-352-27 1042.2 L in 1 TANK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/17/2019 Labeler - DeLaval Inc. (173704867) Registrant - West Agro, Inc. (069288728) Establishment Name Address ID/FEI Business Operations West Agro, Inc. 147528723 manufacture, api manufacture, analysis, label, pack Establishment Name Address ID/FEI Business Operations K Klean dba West Agro, Inc. 002222368 manufacture, api manufacture, analysis, label, pack Establishment Name Address ID/FEI Business Operations West Agro, Inc. 095906480 manufacture, api manufacture, analysis, label, pack Establishment Name Address ID/FEI Business Operations Alliance Dairy Service & Supplies Inc. 117084685 repack Establishment Name Address ID/FEI Business Operations West Agro, Inc. 069288728 api manufacture, manufacture, pack, label