CLOUD9 HAND SANITIZER S- ethyl alcohol liquid 
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.

----------

Active Ingredient(s)

Ethyl alcohol 80%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on hands.
Recommended for repeated use.

Warnings

For external use only.

Flammable - Keep away from fire or flame

When using this product

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, Hydrogen Peroxide

Package Label - Principal Display Panel

500 mL NDC: 73330-0012-1

500ml label

100 mL NDC: 73330-0012-2

100ml label

CLOUD9 HAND SANITIZER S 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73330-0013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73330-0013-1500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
2NDC:73330-0013-2100 mL in 1 BOTTLE, SPRAY; 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(73330-0013)

Revised: 4/2020
Document Id: a41b4084-9c8b-8d72-e053-2995a90a32f1
Set id: a41b3de5-e062-75f2-e053-2a95a90aa6e4
Version: 1
Effective Time: 20200425
 
COSNINE Inc