HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Landy International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin.

Warning

For external use only.
When using this product avoid contact with eyes.In case of contact flush eyes thoroughly with water.

Flammable.
Keep away from heat and flame.

Stop use and consult a doctor
if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children.

If swallowed,get medical help or contact Poison Control Center right away

Directions

■ Wet hands with product and allow to dry without wiping.

Children under 6 years of age should be supervised when using this product.

Other Information

do not store above 104F (40C)
may discolor certain fa surfaces.

Inactive Ingredient

WATER,PHENOXYETHANOL,CARBOMER COPOLYMER TYPE A,SODIUM HYDRIDE,DMDM HYDANTOIN ,FD&C BLUE NO. 1,FD&C YELLOW NO. 5

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER  
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51706-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	red, pink, green, orange, purple, blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51706-600-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/17/2015

Labeler - Landy International (545291775)

Registrant - Landy International (545291775)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(51706-600)