HAND SANITIZER- ethyl alcohol gel 
NPW-USA, 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:
Ethyl alcohol, 62%

Purpose Antiseptic

Warnings:

For external use only.

FLAMMBLE. Keep away from fire or flame.

Stop use and ask a doctor if irritation and redness persists for more than 72 hours.

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center right away.

Directions:

Inactive ingredients: water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, acrylates copolymer, polyethylene terephthalate, red 33, diatomaceous earth.

Other Information:

Do not store in temperatures above 118 F

Uses:

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49435-001
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)  
POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.70-1.00) (UNII: 645M2T7FHZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49435-001-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/11/2016
Labeler - NPW-USA, Inc. (079831598)

Revised: 1/2016
Document Id: 290f5411-fda4-6521-e054-00144ff88e88
Set id: 290f5411-fda2-6521-e054-00144ff88e88
Version: 1
Effective Time: 20160111
 
NPW-USA, Inc.