WATERLESS ANTI BACTERIAL HAND SANITIZER - ethyl alcohol liquid 
Tri-Coastal Design Company 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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Drug Facts

Active Ingredient

Ethyl Alcohol 63%

Purpose

Antiseptic

Uses

Warnings

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions


Other information

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, DC Red 33, FDC Blue 1, Fragrance, Propylene Glycol, Triethanolamine, Water

Package Label

Package Label
image of package label

WATERLESS ANTI BACTERIAL HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-030-03100 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33308/01/2010
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture

Revised: 7/2010
Document Id: 231f30b1-303f-4a81-9d29-def719081a38
Set id: 5833426a-57c3-4606-95ac-9a670221779d
Version: 1
Effective Time: 20100715
 
Tri-Coastal Design Company Inc.