FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Evonik Stockhausen, LLC
Effective date
2011-09-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:57

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Hand antiseptic to decrease bacteria on the skin.

Dosage and administration

Dispense an adequate amount (approx. 5 mL), rubbing all surfaces of both hands for at least15 seconds. Allow to dry without wiping.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol (70%)

Purpose

OTC - PURPOSE SECTION

Hand Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand antiseptic to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable, For external use only.

Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water.

Stop use and ask doctor if

OTC - STOP USE SECTION

Skin or eye irritation persists for more than 72 hours

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

  • Dispense an adequate amount (approx. 5 mL), rubbing all surfaces of both hands for at least15 seconds.
  • Allow to dry without wiping.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Isopropanol, Hydrogenated Starch Hydrolysate, Carbomer, THP Ethylendiamine, Polyacrylic Acid.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64064-003-04

Instant Hand

Sanitizer 70%

No Rinsing

Desinfectant

Instantane Pour Les Mains

Sans Rincage

Clinishield

Manufactured in U.S.A.

Fabrique Aux E.-U.

Evonik Stockhausen, LLC

Greensboro, NC 27406

1-800-334-0242 www.CliniShield.com

Imported by

Trans Canada Distribution Inc.

Mississauga, ON L5L 5Y7

Net Contents 33.82 Fl Oz

1000 (mL)

Contenu Net 1 L

Stock No. 31795

No. De Stock 31795

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IHS 003-04 1000 mLIHS 003-04 1000 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64064-003-042019-11-13C16284748780-197449f38-b5d9-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64064-003-04Instant Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64064-003INSTANT HAND SANITIZER (ALCOHOL) LIQUID [EVONIK STOCKHAUSEN, LLC]1Legacy NDC, 1 package rows20111101_97384b49-a61b-4529-a306-b6e49daede56.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E1
EDETOLINACTIVE INGREDIENTQ4R969U9FR1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64064-00364064-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
EDETOLQ4R969U9FRIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT

Source Document#

Source XML · Source PDF

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EEMULSION / TOPICAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TRANSDERMAL150 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / OPHTHALMIC4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 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
97384b49-a61b-4529-a306-b6e49daede5697384b49-a61b-4529-a306-b6e49daede562011-09-06WarningsExact identifier
spl id: 97384b49-a61b-4529-a306-b6e49daede56
spl set id: 97384b49-a61b-4529-a306-b6e49daede56

Reported adverse events (FAERS/openFDA)#

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