Label: INSTAMIX GLYCOLIC CONCENTRATE- glycerin, glycolic acid concentrate
- NDC Code(s): 55756-157-01, 55756-157-27
- Packager: DeLaval
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 12, 2024
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- PURPOSE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
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.
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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. 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.
- SPL UNCLASSIFIED SECTION
- WARNINGS AND PRECAUTIONS
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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
- WARNINGS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INSTAMIX GLYCOLIC CONCENTRATE
glycerin, glycolic acid concentrateProduct 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