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Waterless Anti-Bacterial Hand Cleanser

Dosage form: liquid
Ingredients: ALCOHOL 62mL in 100mL
Labeler: Tri-Coastal Design Company Inc.
NDC Code: 49852-163

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 62%

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
  • in the case of eye contact, rinse eyes thoroughly with water

Other information
  • store below 105F
  • may discolor some fabrics

Inactive IngredientsBenzophenone-4, Carbomer, FDC Blue 1, Fragrance, Glycerin, Jojoba Oil, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol, Triethanolamine, Water

Package LabelPackage Label

WATERLESS ANTI-BACTERIAL HAND CLEANSER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-163
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GLYCERIN 
JOJOBA OIL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PROPYLENE GLYCOL 
ALPHA-TOCOPHEROL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:49852-163-16473 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33309/01/2010
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIOperations
Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture

Revised: 08/2010
 
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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