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

Warnings

For external use only.

Flammable.Keep away from fire and flame.

Do not apply around eyes.

Do not use in ears and mouth

When using this product

avoid contact with eyes. In case of contact, flush eyes with water.

Avoid contact with broken skin.

Stop use and ask a doctor if

irritation or redness develops or persists.

Keep out of reach of children.

Children under 6, use only under adult supervision. Not recommended for infants.

Directions

Other Information:

Inactive ingredients

Glycerin,Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium Edta, Tocopheryl Acetate, Deionized Water

Packaging

image description

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-006
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:75613-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
2NDC:75613-006-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/22/2020
Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-006)

Revised: 5/2020
Document Id: cd03030e-84ff-4a1d-b9d6-11b5eaf9a073
Set id: d5276ec9-15b9-4438-972d-104157881147
Version: 1
Effective Time: 20200522
 
Ningbo Lanzi Cosmetic Technology Co., Ltd