DREUMEX OMNICARE HAND SANITIZER- alcohol spray 
Dreumex USA, 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.

----------

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

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

Container Label

Carton Label -- package of 6 cans

Carton Label

DREUMEX OMNICARE HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53305-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mg  in 1.2 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 400 mg  in 1.2 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53305-065-026 in 1 CASE12/15/2016
1NDC:53305-065-01400 mL in 1 CAN; Type 0: Not a Combination Product
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/FEIBusiness Operations
Dreumex USA, Inc.003003118label(53305-065)
Establishment
NameAddressID/FEIBusiness Operations
BiB Production and Packaging B.V.409606985manufacture(53305-065)

Revised: 9/2018
Document Id: 673ce252-175b-2ccb-e053-2a91aa0afc11
Set id: ecc8ee22-cf81-4964-80d3-79711875428e
Version: 7
Effective Time: 20180905
 
Dreumex USA, Inc.