MYSTIC- triclosan solution
Kay Chemical Company

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 Facts

Active ingredient

Triclosan 0.3%

Purpose

Antiseptic Handwash

Uses

For handwashing to decrease bacteria on the skin

Warnings

For external use only

Do not use

In eyes

When using this product

If in eyes, rinse promptly and thoroughly with water
Discontinue use if irritation and redness develop

Stop use and ask doctor 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 Material Safety Data Sheet (MSDS)
for emergency medical information in USA call 1-800-391-1504

Inactive ingredients water (aqua), potassium cocoate, alcohol, sodium laureth sulfate, hexylene glycol, boric acid, cocamidopropyl PG-dimonium chloride phosphate, tetrasodium EDTA, cocamine oxide, fragrance, PEG-75 lanolin, methylparaben, propylparaben, aloe barbadensis leaf juice, FDC blue 1

Questions? Call 1-800-532-7732

Principal Display Panel and Representative Label

SSDC

NDC 63146-116-03

MYSTIC

Foaming Anti-Bacterial Hand Soap

Triclosan 0.3%

Net Contents 750 mL/25 US fl oz

Distributed by:

SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732

representative label

MYSTIC
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63146-116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BORIC ACID (UNII: R57ZHV85D4)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
EDETATE SODIUM (UNII: MP1J8420LU)
COCAMINE OXIDE (UNII: QWA2IZI6FI)
PEG-75 LANOLIN (UNII: 09179OX7TB)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63146-116-03	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/22/2010	04/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/22/2010	04/07/2018

Labeler - Kay Chemical Company (003237021)

Revised: 3/2018

Document Id: 1ace881c-991b-443a-b78e-c887dcb0768b

Set id: 22e5c2a8-35a2-4cad-ac75-ab96eab20ef9

Version: 3

Effective Time: 20180302

Kay Chemical Company