FDA.reportPublic FDA data

Deb Med InstantFOAM OptiDose Hand Sanitizer

Manufacturer
Deb USA, Inc. | Deb Worldwide Healthcare Inc.
Effective date
2012-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:29

Label at a glance#

ProductDeb Med InstantFOAM OptiDose Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

For hand sanitizing to reduce bacteria on skin

Dosage and administration

Apply foaming sanitizer to cover dry hands Rub into skin No rinsing required

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% w/w

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing to reduce bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Flammable: Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply foaming sanitizer to cover dry hands

Rub into skin

No rinsing required

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Bis-PEG-12 Dimethicone, Behentrimonium Chloride, PEG-200 Hydrogenated Glyceryl Palmate, PEG-7 Glyceryl Cocoate, Coco-Glucoside, Glyceryl Oleate, Dihydroxypropyl PEG-5 Linoleammonium Chloride.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

deb med

Engineering Hand Hygiene Compliance

NDC 11084-200-27

optidose

InstantFOAM moisturing hand sanitizer

Certified EcoLogo

Certified Instant Hand Antiseptic CCD-170

USDA Certified Biobased Product

Made in Canada

US Patents 5,445,288 & 6,082,586

Worldwide Patent Pending.

Made by Deb for:

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debmed.com

NSF

Nonfood Compounds Program Listed E3

140062

DMIFS1L

1 Liter 33.8 fl. oz.

Rev. 10-12

DMIFS1L Optidose labelDMIFS1L Optidose label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616805ethanol 70 % Topical FoamPSN1
616805ethanol 0.7 ML/ML Topical FoamSCD1
616805ethanol 70 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11084-200-272020-01-31C16284748780-19d75b9d0-3af0-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-200-27Deb Med InstantFOAM OptiDose Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-200DEB MED INSTANTFOAM OPTIDOSE HAND SANITIZER (ETHYL ALCOHOL) LIQUID [DEB USA, INC.]1Legacy NDC, 1 package rows20121101_2dde5b59-3324-4738-97e7-ab0a90ba6198.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
BEHENTRIMONIUM CHLORIDEINACTIVE INGREDIENTX7GNG3S47T1
COCO GLUCOSIDEINACTIVE INGREDIENTICS790225B1
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDEINACTIVE INGREDIENT0Y0NQR2GH11
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GLYCERYL COCOATEINACTIVE INGREDIENTWVK1CT59941
GLYCERYL MONOOLEATEINACTIVE INGREDIENT4PC054V79P1
PEG-200 DILAURATEINACTIVE INGREDIENTTWV5J70L881
PROPYL ALCOHOLINACTIVE INGREDIENT96F264O9SV1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11084-20011084-200-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIM
WATER059QF0KO0RIACT
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE0Y0NQR2GH1IACT
PROPYL ALCOHOL96F264O9SVIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
DIMETHICONE92RU3N3Y1OIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERYL MONOOLEATE4PC054V79PIACT
PEG-200 DILAURATETWV5J70L88IACT
GLYCERYL COCOATEWVK1CT5994IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERYL MONOOLEATEGLYCERYL OLEATE4PC054V79PPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL MONOOLEATEGLYCERYL OLEATE4PC054V79PCREAM, AUGMENTED / TOPICAL3.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
PROPYL ALCOHOLPROPYL ALCOHOL96F264O9SVPOWDER / TOPICAL0.4 mg/mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERYL MONOOLEATEGLYCERYL OLEATE4PC054V79PCAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL MONOOLEATEGLYCERYL OLEATE4PC054V79PSPRAY / TOPICAL0.95 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL MONOOLEATEGLYCERYL OLEATE4PC054V79PFILM, EXTENDED RELEASE / TRANSDERMAL18.8 mgExact identifier — unii candidate
7 equally ranked IID candidates
PROPYL ALCOHOLPROPYL ALCOHOL96F264O9SVSOLUTION / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERYL MONOOLEATEGLYCERYL OLEATE4PC054V79PTABLET / ORAL3 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL MONOOLEATEGLYCERYL OLEATE4PC054V79PGEL / TOPICAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
PROPYL ALCOHOLPROPYL ALCOHOL96F264O9SVOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
3 equally ranked IID candidates

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
ed8e2b7b-bb06-4035-93c9-9b277bd60b992dde5b59-3324-4738-97e7-ab0a90ba61982012-10-30WarningsExact identifier
spl id: ed8e2b7b-bb06-4035-93c9-9b277bd60b99
spl set id: 2dde5b59-3324-4738-97e7-ab0a90ba6198

Reported adverse events (FAERS/openFDA)#

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