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SPL UNCLASSIFIED SECTION
IMPORTANT
This is a bulk packaged product. It is not intended for use in its present form. Further processing is in accordance with all application standards and regulations. Storage conditions: 30% to 50% relative humidity at 59 degrees - 86 degrees F ( 15 degrees - 30 degrees C). Do not refrigerate.
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Bulk Packaged Product Label Drug
Best Formulations 17758 Rowland Street City of Industry, CA 91748 (626) 912-9998
DESCRIPTION
PRODUCT: VIT. K-1 GEL CAPS
CODE: DR5005
SIZE: 5 Oval
LOT NO.: L11027
NET WEIGHT: 16.33 Lbs
COUNT: 23,000 Softgels
MFG DATE: 01 - 2012
BY: M.Z.
INGREDIENTS
Vitamin K-1 Phytonadione, Soybean Oil, Gelatin, Glycerin, Purified Water, FDandC Blue # 1, Titanium Dioxide
DRUG
IMPORTANT
This is a bulk packaged product. It is not intended for use in its present form. Further processing is in accordance with all application standards and regulations. Storage conditions: 30% to 50% relative humidity at 59 degrees - 86 degrees F ( 15 degrees - 30 degrees C). Do not refrigerate.
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INGREDIENTS AND APPEARANCE
5VET002 VETA K-1
phytonadione capsule, liquid filledProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:66201-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE 25 mg in 25 mg Inactive Ingredients Ingredient Name Strength SOYBEAN OIL (UNII: 241ATL177A) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown (OPAQUE BROWN) Score no score Shape OVAL (SOFTGEL) Size 5mm Flavor Imprint Code NONE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66201-002-01 25 mg in 1 CAPSULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 Labeler - Best Formulations Inc. (147341796) Registrant - Best Formulations Inc. (147341796) Establishment Name Address ID/FEI Business Operations Best Formulations Inc. 147341796 manufacture, api manufacture