Label: ECOLAB INC.- benzalkonium chloride solution
- NDC Code(s): 47593-513-62
- 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 July 18, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
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Directions: Concentrated Solution
- do not mix with anything except for potable water
- use only provided bottles for diution and dispensing of ready-to-use product
- remove cap, open dispenser door, place bottle into position, and close dispenser door
- fill hand soap bottle with solution from dispenser
- place bottle into a Nexa or Syncra dispenser for use
- Directions: Ready-To-Use Solution
- Other information
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INACTIVE INGREDIENT
Inactive ingredients water (aqua), cocamine oxide, glycerin, cocamidopropyl PG-dimonium chloride phosphate, hexylene glycol, methyl gluceth-20, PEG 7 glyceryl cocoate, potlyquaternium-77, polyquaternium-7, tetrasodium EDTA, PEG-12 dimethicone, lactic acid, glyceth-18 ethylhexanoate, ethanol, magnesium nitrate, fragrance, glycereth-18, methylchloroisothiazolinone, magnesium chloride, DC red 33, mehtylisothiazolinone
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INGREDIENTS AND APPEARANCE
ECOLAB INC.
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-513 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 8.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMINE OXIDE (UNII: QWA2IZI6FI) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) HEXYLENE GLYCOL (UNII: KEH0A3F75J) METHYL GLUCETH-20 (UNII: J3QD0LD11P) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) EDETATE SODIUM (UNII: MP1J8420LU) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) LACTIC ACID (UNII: 33X04XA5AT) GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y) ALCOHOL (UNII: 3K9958V90M) MAGNESIUM NITRATE (UNII: 77CBG3UN78) GLYCERETH-18 (UNII: SA5E43C17C) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) D&C RED NO. 33 (UNII: 9DBA0SBB0L) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47593-513-62 1300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/26/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/26/2015 Labeler - Ecolab Inc. (006154611)