Label: MYSTIC- benzalkonium chloride solution
- NDC Code(s): 63146-304-03, 63146-304-10
- Packager: Kay Chemical Company
- 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 November 14, 2022
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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
SSDC
Sustainable Solutions
MYSTIC™
Foaming Anti-Bacterial Hand Soap
Jabón para manos con espuma antibacterial
Benzalkonium chloride 0.5%
1112019
Net Content/Contenido Neto: 750mL/25 US fl. oz.
Distributed by:
SSDC Division, Kay Chemical Company
4050 Corporate Drive, #100
Grapevine, Texas 76051, USA 800.532.7732
©2020 Kay Chemical Company All Rights Reserved
749431 749431/7303/0920
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INGREDIENTS AND APPEARANCE
MYSTIC
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63146-304 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) METHYL GLUCETH-20 (UNII: J3QD0LD11P) MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9) PHENOXYETHANOL (UNII: HIE492ZZ3T) MYRISTAMINE OXIDE (UNII: J086PM3RRT) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) HEXYLENE GLYCOL (UNII: KEH0A3F75J) WATER (UNII: 059QF0KO0R) COCAMINE OXIDE (UNII: QWA2IZI6FI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63146-304-03 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/11/2016 2 NDC:63146-304-10 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/11/2016 Labeler - Kay Chemical Company (003237021)