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(s)

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

■decreases bacteria on the skin that could cause disease
■recommended for repeated use

Warnings

For external use only: hands
Flammable, keep away from fire or flame.
When using this product
■keep out of eyes. In case of contact with eyes flush thoroughly with water.
avoid contact with broken skin
■do not inhale or ingest
Stop use and ask doctor if
■irritation and redness develop
n condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

■wet hands thoroughly with product and allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Inactive ingredients

Inactive Ingredient Water(Aqua), Acrylates/C10 30 alkyl arylate crosspolymer,
Glycerin, Triethanolamine, Fragrance (Parfum), Tocopheryl Acetate, Aloe barbadensis-
leaf extract, Denatonium Benzoate, Phenoxyethanol, Ethylhexylglycerin.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51706-902
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51706-902-01	975 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020

Labeler - Landy International (545291775)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(51706-902)