DREUMEX OMNICARE HAND SANITIZER- alcohol spray

Dreumex Omnicare Hand Sanitizer by

Drug Labeling and Warnings

Dreumex Omnicare Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dreumex USA, Inc., BiB Production and Packaging B.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DREUMEX OMNICARE HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53305-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	800 mg  in 1.2 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	400 mg  in 1.2 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53305-065-02	6 in 1 CASE	12/15/2016
1	NDC: 53305-065-01	400 mL in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2012

Labeler - Dreumex USA, Inc. (003003118)

Establishment
Name	Address	ID/FEI	Business Operations
Dreumex USA, Inc.		003003118	label(53305-065)

Establishment
Name	Address	ID/FEI	Business Operations
BiB Production and Packaging B.V.		409606985	manufacture(53305-065)