SURE WELL HAND SANITIZER (ETHANOL)- ethyl alcohol gel 
COSNINE, Inc.

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 68%

Purpose

Antiseptic

Uses

Decrease bacteria on hands
Recommended for repeated use.

Warnings

For external use only.

Flammable - Keep away from fire or flame

When using this product

avoid contact with eyes.

if contact occurs, rinse thoroughly with waterr

Stop use and ask a doctor

if irritation and redness develop or increase.

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine

Package Label - Principal Display Panel

500 mL NDC: 73330-0016-1

500ml_Label

SURE WELL HAND SANITIZER (ETHANOL) 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73330-0016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73330-0016-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - COSNINE, Inc. (694607163)
Establishment
NameAddressID/FEIBusiness Operations
COSNINE, INC.694607163manufacture(73330-0016)

Revised: 6/2020
Document Id: a8e1fa9e-b90f-bf0d-e053-2995a90a5a56
Set id: a8e1fa9e-b90e-bf0d-e053-2995a90a5a56
Version: 1
Effective Time: 20200625
 
COSNINE, Inc.