Label: KEYSTONE- benzalkonium chloride solution
- NDC Code(s): 47593-561-41
- 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 June 6, 2019
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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 Foaming Hand Soap
Active Ingredient: Benzalkonium chloride 0.5%
Sysco® 4596843 6101146 ECOLAB®
750 mL (25.3 US FL OZ) 764502/5401/0918
This product may be patented: www.ecolab.com/patents
For SDS information visit:
www.cleanwithkeystone.com
Ecolab · 1 Ecolab Place · St Paul MN 55102 USA ·
tel: 1 800 35 CLEAN (352 5326)
© 2018 Ecolab USA Inc. · All rights reserved
Made in U.S.A.
www.ecolab.com
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INGREDIENTS AND APPEARANCE
KEYSTONE
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-561 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 POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9) WATER (UNII: 059QF0KO0R) COCAMINE OXIDE (UNII: QWA2IZI6FI) HEXYLENE GLYCOL (UNII: KEH0A3F75J) 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) MYRISTAMINE OXIDE (UNII: J086PM3RRT) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYL GLUCETH-20 (UNII: J3QD0LD11P) GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85) 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:47593-561-41 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/21/2016 Labeler - Ecolab Inc. (006154611)