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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51706-904 Moisturizing hand sanitizer 62% alcohol advanced formula with Vitamin E

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

WaterAqua), Glycerin, Acrylates/C10-30-alky| acrylate crosspolymer, Triethanolamine, Fragrance (Parfum),
Tocopheryl acetate, Denatonium benzoate.

Package Label - Principal Display Panel

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-904
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51706-904-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2020

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

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-904)