MYSTIC- benzalkonium chloride solution

Mystic by

Drug Labeling and Warnings

Mystic by is a Otc medication manufactured, distributed, or labeled by Kay Chemical Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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: 63146-304-10	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 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)