WATERLESS ANTI BACTERIAL HAND SANITIZER- ethyl alcohol liquid

waterless anti bacterial hand sanitizer by

Drug Labeling and Warnings

waterless anti bacterial hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Tri-Coastal Design Company Inc. , Landy International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 63%

Purpose

Antiseptic

Uses

• For handwashing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

• For external use only
• Flammable, keep away from fire and flame
• Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

When using this product

• avoid the eyes an mucous membranes
• in the case of eyes or mucous membrane contact; rinse area thoroughly with water
  

Stop use and ask a doctor if

• condition worsens
• redness or irritation develops
• if condition persists for more than 3 days
  

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

• Rub quarter sized amount between hands until dry
• Supervise children in the use of this product

Other information

• Store below 105F
• May discolor some fabrics
  

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, FDC Red 4, FDC Yellow 5, Fragrance, Propylene Glycol, Triethanolamine, Water

Package Label

Package Label

INGREDIENTS AND APPEARANCE

WATERLESS ANTI BACTERIAL HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49852-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49852-032-03	100 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	08/01/2010

Labeler - Tri-Coastal Design Company Inc. (609734900)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture