HAND SANITIZER- alcohol gel 
Ningbo Lanzi Cosmetic Technology Co., Ltd

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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HAND SANITIZER

Drug Facts

Active ingredient

Ethyl Alcohol 62%

Purpose

 Antiseptic

Use

hand sanitizing to reduce bacteria on skin.

Warnings

For external use only

Flammable. Keep away from fire and flame.

When using this product

do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place product on hands, rub until dry.

Inactive ingredients

Glycerin, Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium edtatocopheryl acetate, Deionized Water

Packaging

image description

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-005
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
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75613-005-018 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/23/202006/24/2020
2NDC:75613-005-0210 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/23/202006/24/2020
3NDC:75613-005-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/23/2020
Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-005)

Revised: 6/2020
Document Id: f22c535f-0233-41ca-8647-49ae1703e0a7
Set id: 8ea55574-404d-49e2-a8b0-80e9e366c77c
Version: 10
Effective Time: 20200623
 
Ningbo Lanzi Cosmetic Technology Co., Ltd