HAND SANITIZER- alcohol gel 
Newacme llc

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 70% v/v

Purpose

Antiseptic

Use

For hand washing to decrease bacteria ont he skin.

Warnings

Flammable. Keep away from fire or flame.

For External Use Only

When using this product

avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask a doctor

if skin irritation or rash develops and continues for more than 72 hours.

Keep out of reach of children.

If swallowed get medical help or contact your Poison Control right away.

Directions

Other information

Inactive ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

Package Labeling: 15 ml

Label

Package Labeling: 53 ml

Label2

Package Labeling: 60 ml

Label3

Package Labeling: 473 ml

Label4

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74341-194
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74341-194-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
2NDC:74341-194-5353 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/202012/31/2021
3NDC:74341-194-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
4NDC:74341-194-73473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/20/2020
Labeler - Newacme llc (117465743)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Ayan Biotech Co.,Ltd.544377996manufacture(74341-194)

Revised: 1/2022
Document Id: d61e6cfd-1b20-513f-e053-2995a90ae219
Set id: b60ace2f-bdf2-49cd-bd76-6cced71704f0
Version: 3
Effective Time: 20220121
 
Newacme llc