Active Ingredient

Benzalkonium chloride 0.5%

Purpose

Antiseptic handwash

Uses

for handwashing to decrease bacteria on the skin

Warnings

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 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

Questions? Call 1-800-532-7732

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

749431 749431/7303/0920

Representative label

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:63146-304-03	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 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)

Drug Facts