HAND SANITIZER- ethyl alcohol gel 
Landy International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

1

2

3456

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-911
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-911-01325 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/2020
Labeler - Landy International (545291775)
Registrant - Landy International (545291775)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51706-911)

Revised: 3/2022
Document Id: dab8f517-b06c-da02-e053-2995a90a6ec8
Set id: aa84144a-1758-3c7b-e053-2995a90a968f
Version: 2
Effective Time: 20220321
 
Landy International