DREUMEX OMNICARE HAND SANITIZER- alcohol gel 
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.

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Active Ingredient

Ethyl Alcohol, 80%

Purpose

Antibacterial

Uses

for hand cleansing 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 aned 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 (49°C).

Keep out of reach of children.

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

Directions

  • apply palmful to hands
  • scrub thoroughly until dry

Inactive Ingredients

water, panthenol, glycerin, cetyl alcohol, propylene glycol, acrylates/C 10-30 alkyl acrylate crosspolymer, aminomethyl propanol.

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

Container Label

DREUMEX OMNICARE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53305-075
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:53305-075-026 in 1 CASE12/01/201612/15/2016
1NDC:53305-075-01400 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 finalpart333E11/01/201212/31/2018
Labeler - Dreumex USA, Inc. (003003118)
Establishment
NameAddressID/FEIBusiness Operations
Dreumex USA, Inc.003003118label(53305-075)
Establishment
NameAddressID/FEIBusiness Operations
BiB Production and Packaging B.V.409606985manufacture(53305-075)

Revised: 9/2018
Document Id: 75252cd3-d9ee-62c7-e053-2a91aa0a7909
Set id: 3d4ff6d5-b60a-4df3-ab68-23cb2c9ce1e6
Version: 7
Effective Time: 20180905
 
Dreumex USA, Inc.