Label: KEYSTONE- benzalkonium chloride solution
- NDC Code(s): 47593-595-41
- Packager: Ecolab Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 18, 2018
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- Active Ingredient
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INACTIVE INGREDIENT
Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, polyquaternium-7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1
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Representative Label and Principal Display Panel
KEYSTONE SYSCO
ADVANCED ANTIBACTERIAL FOAM HAND SOAP
Active ingredient: Benzalkonium chloride 0.5%
Sysco 5284789 6101971 ECOLAB®
Net Contents
750 mL (25.3 US FL OZ) 6101971
This product may be patented: www.ecolab.com/patents
For SDS information visit:
www.cleawnwithkeystone.com
Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA
© 2018 Ecolab USA Inc. · All rights reserved
Made in United States
www.ecolab.com · 773738/5401/1018
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INGREDIENTS AND APPEARANCE
KEYSTONE
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-595 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMINE OXIDE (UNII: QWA2IZI6FI) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYL GLUCETH-20 (UNII: J3QD0LD11P) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) ALCOHOL (UNII: 3K9958V90M) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) POTASSIUM CITRATE (UNII: EE90ONI6FF) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47593-595-41 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/20/2018 Labeler - Ecolab Inc. (006154611)