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waterless anti bacterial hand sanitizer

Medically reviewed on July 16, 2018

Dosage form: liquid
Ingredients: ALCOHOL 63mL in 100mL
Labeler: Tri-Coastal Design Company Inc.
NDC Code: 49852-030

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.

Drug Facts

Active Ingredient

Ethyl Alcohol 63%

Purpose

Antiseptic

Uses
  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use

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

When using this product
  • avoid the eyes an mucous membranes
  • in the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop use and ask a doctor if
  • condition worsens
  • redness or irritation develops
  • if condition persists for more than 3 days

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions
  • Rub quarter sized amount between hands until dry
  • Supervise children in the use of this product

Other information
  • Store below 105F
  • May discolor some fabrics

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

Package LabelPackage Label

WATERLESS ANTI BACTERIAL HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL63 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A 
D&C RED NO. 33 
FD&C BLUE NO. 1 
PROPYLENE GLYCOL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
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/FEIOperations
Landy International545291775manufacture

 
Tri-Coastal Design Company Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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