Dreumex Omnicare Hand Sanitizer

Manufacturer
Dreumex USA, Inc. | BiB Production and Packaging B.V.
Effective date
2018-09-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:56:44

Label at a glance#

ProductDreumex Omnicare Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

For hand cleaning to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

apply a palmful to hands scrub thoroughly until dry

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, 80%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

For hand cleaning to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

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

When using this product

OTC - WHEN USING SECTION

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

OTC - ASK DOCTOR SECTION

if irritation or redness develops.

Contents under pressure.

STORAGE AND HANDLING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply a palmful to hands
  • scrub thoroughly until dry

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water panthenol, glycerin, cetyl alcohol, propylene glycol.

For questions or comments

OTC - QUESTIONS SECTION

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

Principal Display Panel -- Label on individual unit can

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container LabelContainer Label

Carton Label -- package of 6 cans

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53305-065-022020-01-31C16284748780-19d75b9d0-3829-f424-e053-dadaa90a57ceecc8ee22-cf81-4964-80d3-79711875428e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53305-065-01Dreumex Omnicare Hand Sanitizer400 mL in 1 CANSPRAY4007
53305-065-02Dreumex Omnicare Hand Sanitizer6 in 1 CASESPRAY67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53305-065DREUMEX OMNICARE HAND SANITIZER (ALCOHOL) SPRAY [DREUMEX USA, INC.]7Legacy NDC, 2 package rows20180906_ecc8ee22-cf81-4964-80d3-79711875428e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M3
ALCOHOLACTIVE MOIETY3K9958V90M3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53305-06553305-065-01, 53305-065-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
673ce252-175b-2ccb-e053-2a91aa0afc11ecc8ee22-cf81-4964-80d3-79711875428e2018-09-05WarningsExact identifier
spl id: 673ce252-175b-2ccb-e053-2a91aa0afc11
spl set id: ecc8ee22-cf81-4964-80d3-79711875428e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.