HAND SANITIZER- ethyl alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Simoniz USA, Inc., Best Sanitizers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 62%

Purpose

Hand Sanitizer

Uses

• For hand sanitizing to decrease bacteria on the skin.
• Recommended for repeated use

Warnings

• For external use only
• Flammable, keep away from fire or flame

WHEN USING

When using this product

• Do not use in or near eyes
• Use in a well-ventilated area
• Discontinue use if irritation and redness develop

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

• Dispense a small amount of gel into palm of hand
• Rub thoroughly over all surfaces of both hands
• Rub hands together until dry

Other information

• Store in a cool dry place below 104°F

Inactive ingredients

DEA-C8-18 perfluoroalkylethyl phosphate, Glycereth-2 cocoate, Water, Denatoniom Benzoate, Tert-Butyl Alcohol

QUESTIONS

Questions?

Contact Simoniz Mon-Fri 8am-5pm EST at 1-800-227-5536

Bolton, CT 06043

SaniCheck

HAND SANITIZER

Antiseptic Foam

Kills 99.999% of most Germs Without Water

Hospital Approved

250 mL - (8.45 fl oz)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63900-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63900-130-04	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/03/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/03/2015

Labeler - Simoniz USA, Inc. (058510272)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers		627278224	manufacture(63900-130)