ANTIBACTERIAL HAND SANITIZER- antibacterial hand sanitizer gel 
Zhejiang Innoadir Industry and Trade 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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Active Ingredient(s)

Ethyl Alcohol 62% v/v. Purpose: Antibacterial

Purpose

Antibacterial

Use

For hand washing to decrease bacteria on the skin

Warnings

Flammable. Keep away from fire or fame

Do not use

When using this product avoidontact with eyes. lf contact occurrinse eyes thoroughly with water.

Stop use and ask a doctor ifimitaton or rash develops andcontinues for more than 72 hours

Keep out of reach of children.If swallowed, get modical help orcontact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aloe Barbadensis Leaf Extract, CarbomerFragrance, Gycein, Prolene Glycol, Tocopherol Acetate,Triethanolamine, Water

Package Label - Principal Display Panel

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ANTIBACTERIAL HAND SANITIZER 
antibacterial hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76716-006
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
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76716-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
2NDC:76716-006-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
3NDC:76716-006-0390 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
4NDC:76716-006-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
5NDC:76716-006-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/13/2020
Labeler - Zhejiang Innoadir Industry and Trade Co.,Ltd (411892772)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Innoadir Industry and Trade Co.,Ltd411892772manufacture(76716-006)

Revised: 5/2020
Document Id: a5832a3e-89b7-fd8a-e053-2a95a90a2b01
Set id: a58336b8-54e1-c42a-e053-2a95a90ac044
Version: 1
Effective Time: 20200513
 
Zhejiang Innoadir Industry and Trade Co.,Ltd