HAND SANITIZER- 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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51706-903 hand sanitizer 62% alcohol

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. 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

1

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-903
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-903-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/27/2020
Labeler - Landy International (545291775)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51706-903)

Revised: 3/2022
Document Id: dabb9e08-1152-52f4-e053-2a95a90a3290
Set id: a6469b6c-a141-4bd3-e053-2995a90a8a20
Version: 3
Effective Time: 20220321
 
Landy International