ANTI BACTERIAL HAND SANITIZER - 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

  • For handwashing to decrease bacteria on the skin

Warnings

  • For external use only
  • Flammable, keep away from fire and flame
Does not contain grain alcohol. Do not drink. If taken internally will produce serious gastric disturbances

Avoid the eyes and mucous membranes.
In case of contact; rinse area thoroughly with water

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

Rub dime sized amount between hands until dry

Other information

Store below 105F
May discolor some fabrics

Inactive Ingredients

Benzophenone-4, Carbomer, Fragrance, FDC Blue 1, DC Red 33, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol and Jojoba Oil, Triethanolamine, Water (Aqua)

Package Label

Package Label
image of package label

ANTI BACTERIAL HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49852-160
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SULISOBENZONE 
FD&C BLUE NO. 1 
D&C RED NO. 33 
GLYCERIN 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PROPYLENE GLYCOL 
TOCOPHEROL 
JOJOBA OIL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-160-3030 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/15/2011
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture

Revised: 10/2011
Document Id: 418417a8-fb7e-4fc6-901c-4dd4ac344bb1
Set id: bb3868fd-3cb0-47e6-aeb1-39bedda367f6
Version: 1
Effective Time: 20111016
 
Tri-Coastal Design Company Inc.