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Dreumex Omnicare Hand Sanitizer

Dosage form: spray
Ingredients: ALCOHOL 800mg in 1.2mL
Labeler: Dreumex USA, Inc.
NDC Code: 53305-065

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.

Active Ingredient

Ethyl Alcohol, 80%

Purpose

Antibacterial

Uses

For hand cleaning to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame. No Smoking.

When using this product

avoid contact with face, eyes and broken skin. If eye contact occurs, rinse eyes thoroughly with water and seek medical advice.

Stop use and ask a doctor

if irritation or redness develops.

Contents under pressure.

Do not puncture or incinerate. Do not store at temperatures above 120°F (50°C).

Keep out of reach of children.

If swallowed get medical help, or contact a poison control center immediately.

Directions
  • apply a palmful to hands
  • scrub thoroughly until dry

Inactive Ingredients

water panthenol, glycerin, cetyl alcohol, propylene glycol.

For questions or comments

or to report any adverse reactions or side effects, please call 1-800-233-9382.

Principal Display Panel -- Label on individual unit can

Carton Label -- package of 6 cans

DREUMEX OMNICARE HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53305-065
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL800 mg  in 1.2 mL
Inactive Ingredients
Ingredient NameStrength
WATER400 mg  in 1.2 mL
Packaging
#Item CodePackage Description
1NDC:53305-065-026 CAN in 1 CASE
1NDC:53305-065-01400 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/01/2012
Labeler - Dreumex USA, Inc. (003003118)
Establishment
NameAddressID/FEIOperations
Dreumex USA, Inc.003003118label(53305-065)
Establishment
NameAddressID/FEIOperations
BiB Production and Packaging B.V.409606985manufacture(53305-065)

Revised: 12/2016
 
Dreumex USA, Inc.

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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