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)

EthyI 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■irrtation and redness develop m 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
I not recommended for infants

Inactive ingredients

Inactive Ingredients Water(Aqua), AcrlatesC10-30 alky-
acrylate crosspolymer, Glycerin, Triethanolamine, Fragrance (Parfum),
Tocophery| acetate, Aloe barbadensis leaf extract, Denatonium Benzoate,
Phenoxyethanol, Etyhexylglycerin, Yellow 5(CI 19140),
Blue 1(CI 42090).

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51706-903
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
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51706-903-01	355 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(51706-903)