WATERLESS ANTI-BACTERIAL HAND CLEANSER - 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 62%

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

Benzophenone-4, Carbomer, DC Orange 4, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol, Jojoba Oil, Triethanolamine, Water

Package Label

Package Label
image of package label

WATERLESS ANTI-BACTERIAL HAND CLEANSER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-015
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
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-015-08250 mL in 1 BOTTLE, PLASTIC
2NDC:49852-015-6060 mL in 1 BOTTLE, PLASTIC
3NDC:49852-015-4545 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33312/01/2009
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture

Revised: 11/2009
Document Id: 91c7dcb7-fa0e-426b-9872-ed5b2375b2d7
Set id: e72b896d-f908-4dc3-97ae-9a9151608858
Version: 1
Effective Time: 20091127
 
Tri-Coastal Design Company Inc.