51706-911 Hand Sanitizer Ethyl Alcohol(62%)

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]

HAND SANITIZER- ethyl alcohol gel 
Landy International

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51706-911 Hand Sanitizer Ethyl Alcohol(62%)

Active Ingredient(s)

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

decreases bacteria on the skin that could cause disease
I 1 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 condition persists for more than 72 hours

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 Ingredients Water(aqua),fragrance (parfum ),
Acrylates/C10-30 alkyl acrylate crosspolymer, Glycerin,
Triethanolamine, Tocopheryl acetate, Aloe barbadensis leaf extract,
Denatonium benzoate, Phenoxyethanol, Etylhexylglycerin

Package Label - Principal Display Panel

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51706-911
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51706-911-01	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/15/2020	10/06/2024

Labeler - Landy International (545291775)

Registrant - Landy International (545291775)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(51706-911)

Revised: 10/2024

Document Id: 23ccd184-b263-e4c8-e063-6394a90a3f48

34390-5

Set id: aa84144a-1758-3c7b-e053-2995a90a968f

Version: 3

Effective Time: 20241006