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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Active Ingredient(s)

Alcohol denat 62%

Purpose

Antiseptic

Use

for hadwashing to decrease bacteria on the skin

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

dose not contain grain alcohol,do not drink,if taken internally will produce serious gastric distubances.

When using this product

avoid contact with eyes,if contact occurs,flush eyes with water

avoid contact with broken skin

Stop use and ask a doctor if condition worsens

redness or irrtation develops

contidion persists fro more than 3 days

Keep out of reach of children.

in case of accidental ingestion ,seek professinal assistance or contact a Poison Control Center immediately.

Directions

Other information

Store at 68° to 77F(20° to 25°c).
Do not store above 105°.
May discolor some fabrics.
Not recommended for infants.
Harmful to wood finishes and
plastics.

Inactive ingredients

Water(Aqua), Glycerin, Carbome,Triethanolamine, Fragrance(Parfum),Lactose,
Cellulose, Hydroxypropyl Methylcellulose,Jojoba Estes, locopheryl Acetate, Ascorbyl,Palmitate, Ultramarines(CI 77007),
D&C Red NO.33(CI 17200),FD&C YVellow No.5(Cl 19140).

Package Label - Principal Display Panel

30 mL WMCA20S021-1 NDC: 51706-964-01

1

30 mL WMCA20S039 NDC: 51706-964-02

2

30 mL WST21A066 NDC: 51706-964-03

3

30 mL WST21A070R NDC: 51706-964-04

4

30 mL WST21A065B NDC: 51706-964-05

5

30 mL WST21A065P NDC: 51706-964-06

6

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-964
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
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-964-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
2NDC:51706-964-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
3NDC:51706-964-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
4NDC:51706-964-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
5NDC:51706-964-0530 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
6NDC:51706-964-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2020
Labeler - Landy International (545291775)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51706-964)

Revised: 5/2021
Document Id: c2a66cdb-0a0e-9c22-e053-2a95a90aa11e
Set id: c2a66a38-a331-c837-e053-2995a90afb91
Version: 1
Effective Time: 20210518
 
Landy International