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 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 eyes and mucous membranes

In case of contact, rinse area throoughly 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 105°F

May discolor some fabrics

Inactive Ingredients

Benzophenone-4, Carbomer, Fragrance, FD&C Blue 1, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol, Jojoba Oil, Triethanolamine, Water(Aqua)

Package Label

Package Label

ANTI BACTERIAL HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-012
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
SULISOBENZONE (UNII: 1W6L629B4K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TOCOPHEROL (UNII: R0ZB2556P8)  
JOJOBA OIL (UNII: 724GKU717M)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-012-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2011
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 Ltd528039793manufacture(49852-012)

Revised: 12/2018
Document Id: 7e1aaf8c-70ca-2e93-e053-2991aa0a4d34
Set id: d69c1533-56e8-4286-9436-b6549313aff0
Version: 2
Effective Time: 20181228
 
Tri-Coastal Design Company Inc.