FDA.reportPublic FDA data

CoLaboratory Hand Sanitizer

Manufacturer
Doehler USA Inc.
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:48

Label at a glance#

ProductCoLaboratory Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Wet hands with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Storage and handling

Store below 83°F (26.6°C May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol v/v 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

USE

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria that could potentially cause disease. For use when soap and water are not readily available.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

When using this product

  • Avoid contact with eyes. If contact occurs, flush eyes with water.
  • Avoid contact with broken skin.

Stop use and consult doctor if irritation and redness develop and last.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

  • Store below 83°F (26.6°C
  • May discolor certain fabrics or surfaces

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Glycerin, Hydrogen Peroxide, Sodium Hydroxide, Water

SPL UNCLASSIFIED SECTION

alcohol antiseptic 70%

topical solution

non-sterile solution

Doehler North America
400 High Point Road SE
Cartersville, GA

for consumer complaints
please call 770 387 0451
select the prompt to customer service

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ColabnwColabnw

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77278-001-012022-01-28C16284748780-1d6a99b39-8e15-a426-e053-dadaa90af4c2CoLaboratory Hand Sanitizer
77278-001-022022-01-28C16284748780-1d6a99b39-8e15-a426-e053-dadaa90af4c2CoLaboratory Hand Sanitizer
77278-001-032022-01-28C16284748780-1d6a99b39-8e15-a426-e053-dadaa90af4c2CoLaboratory Hand Sanitizer
77278-001-042022-01-28C16284748780-1d6a99b39-8e15-a426-e053-dadaa90af4c2CoLaboratory Hand Sanitizer
77278-001-052022-01-28C16284748780-1d6a99b39-8e15-a426-e053-dadaa90af4c2CoLaboratory Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77278-001-01CoLaboratory Hand Sanitizer1.83 L in 1 BOTTLESOLUTION1.831
77278-001-02CoLaboratory Hand Sanitizer3.67 L in 1 BOTTLESOLUTION3.671
77278-001-03CoLaboratory Hand Sanitizer18.93 L in 1 PAILSOLUTION18.931
77278-001-04CoLaboratory Hand Sanitizer208.2 L in 1 DRUMSOLUTION208.21
77278-001-05CoLaboratory Hand Sanitizer999.4 L in 1 CONTAINERSOLUTION999.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77278-001COLABORATORY HAND SANITIZER (ALCOHOL) SOLUTION [DOEHLER USA INC.]1Legacy NDC, 5 package rows20200610_a07c08b4-c643-4b58-b7ad-69a6f274080c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77278-00177278-001-01, 77278-001-02, 77278-001-03, 77278-001-04, 77278-001-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

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
bdf466ab-1f20-4f88-929d-cba7feb97e57a07c08b4-c643-4b58-b7ad-69a6f274080c2020-05-18WarningsExact identifier
spl id: bdf466ab-1f20-4f88-929d-cba7feb97e57
spl set id: a07c08b4-c643-4b58-b7ad-69a6f274080c

Reported adverse events (FAERS/openFDA)#

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