Hand Sanitizer

Manufacturer
CMC Group Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach 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

  • Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, propylene glycol, purified water, titanium dioxide

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand sanitizerHand sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN5
581660ethanol 0.62 ML/ML Topical GelSCD5
581660ethanol 62 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49687-0015-02025-01-14C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer
49687-0015-12025-01-14C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer
49687-0015-02024-01-30C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer
49687-0015-12024-01-30C16284748780-11030e364-fd2e-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0015-0Hand Sanitizer0.9 g in 1 BOTTLEGEL0.95
49687-0015-0Hand Sanitizer6 in 1 KITGEL65
49687-0015-1Hand Sanitizer0.9 g in 1 PACKAGEGEL0.95
49687-0015-1Hand Sanitizer6 in 1 BOXGEL65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0015HAND SANITIZER (ALCOHOL) GEL [CMC GROUP INC.]5Current NDC, Legacy NDC, 4 package rows20250116_dcca50e6-0935-401d-a23e-be4d1231dde9.zip

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
49687-001549687-0015-1, 49687-0015-0

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
ndc (package): 49687-0015-1
ndc11 (package): 49687001501
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
ndc (package): 49687-0015-1
ndc11 (package): 49687001501
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
ndc (package): 49687-0015-1
ndc (package): 49687-0015-0
ndc (product): 49687-0015
ndc11 (package): 49687001500
ndc11 (package): 49687001501
spl id: 2b9b7e7d-a481-efea-e063-6294a90ab93d
spl set id: dcca50e6-0935-401d-a23e-be4d1231dde9
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
ndc (package): 49687-0015-0
ndc11 (package): 49687001500

Reported adverse events (FAERS/openFDA)#

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