Mystic (Benzalkonium Chloride) Solution [Kay Chemical Company] -

MYSTIC (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]
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NDC	63146-304-08, 63146-304-10
Set ID	29d05188-581a-484c-88a9-84aa9bbfbb93
Category	HUMAN OTC DRUG LABEL
Packager	Kay Chemical Company
Generic Name
Product Class
Product Number
Application Number	PART333E

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Active Ingredient

Benzalkonium chloride 0.5%
Purpose

Antiseptic handwash
Uses
- for handwashing to decrease bacteria on the skin
Warning
For external use only
Do not use
- in eyes
When using the product
- if in eyes, rinse promptly and thoroughly with water
- discontinue use if irritation and redness develop
Stop use and ask a docotr if
- Skin irritation or redness occurs for more than 72 hours
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Wet hands and forearms
- Dispense a palmful of product to hands
- Scrub hands and forearms for 20 seconds
- Rinse thoroughly and dry
Other information
- for additional information, see Safety Data Sheet (SDS)
- for emergency medical information in USA call 1-800-328-0026
INACTIVE INGREDIENT

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1
QUESTIONS

Questions? Call 1-800-532-7732
Representative Label and Principal Display Panel

NDC 63146-304-10

SSDC

Sustainable Solutions

MYSTIC™

Foaming Anti-Bacterial Hand Soap

Jabón para manos con espuma antibacterial

Active Ingredient

Benzalkonium chloride 0.5%

1110489

Net Content/Contenido Neto: 1250 mL/42.3 US fl. oz.

Distributed by:

SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732

©2016 Kay Chemical Company All Rights Reserved

Made in United States

765697-00 765697/7300/0316

INGREDIENTS AND APPEARANCE

MYSTIC
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63146-304
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63146-304-10	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2016
2	NDC:63146-304-08	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/11/2016

Labeler - Kay Chemical Company (003237021)

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Medic

MYSTIC (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]

Do not use

When using the product

Stop use and ask a docotr if

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