Hand Sanitizer

Manufacturer
S.F. & B. COLOR MATES CORP.
Effective date
2020-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:16

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

■ To decrease bacteria on the skin that could cause disease. ■ Recommended for repeated use

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ To decrease bacteria on the skin that could cause disease. ■ Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only-hands. Flammable. Keep away from heat or flame.

When using this product

OTC - WHEN USING SECTION

■ Keep out of eyes. In case of contact with eyes, flush throughly with water. ■ Do not inhale or ingest. ■ Avoid contact with broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

if skin irritation develops.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

■ Do not store above105ºF ■ May discolor some fabrics ■ Harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Aminomethylpropanol, Aloe Barbadensis Extract

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76781-001-022022-01-28C16284748780-1d6a99b39-d82d-a426-e053-dadaa90af4c2Colormates Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76781-001-02Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76781-001HAND SANITIZER (ALCOHOL) GEL [S.F. & B. COLOR MATES CORP.]1Legacy NDC, 1 package rows20200428_a40b17f7-49f1-467c-e053-2a95a90a6aee.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
76781-00176781-001-02

Ingredients#

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

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

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
a40b15bd-231d-4485-e053-2995a90ad846a40b17f7-49f1-467c-e053-2a95a90a6aee2020-04-24WarningsExact identifier
spl id: a40b15bd-231d-4485-e053-2995a90ad846
spl set id: a40b17f7-49f1-467c-e053-2a95a90a6aee

Reported adverse events (FAERS/openFDA)#

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