FDA.reportPublic FDA data

75% alcohol hand sanitizer

Manufacturer
Pinnacle Brands LLC | Aogrand International Trade Corporation
Effective date
2023-02-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:03

Label at a glance#

Product75% alcohol hand sanitizer
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

For hand sannitizing to reduce bacteria on the skin.

WARNINGS SECTION

Flammable. Keep away from fire or flame. For external use only.

OTC - WHEN USING SECTION

Keep away from eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep our of reach of children.

OTC - DO NOT USE SECTION

Do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or redness develops.

DOSAGE & ADMINISTRATION SECTION

Squeeze small amount in your palm and briskly rub hands together and allow to air dry.

For children under 6, use with adult supervision.

Not recommended for infants.

OTHER SAFETY INFORMATION

Store below 105F (43C). May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT SECTION

Water, Acrylic Polymer, Triethanolamine, Glycerine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237 mL NDC: 74621-001-04

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN4
1305100ethanol 0.75 ML/ML Topical GelSCD4
1305100ethanol 75 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75690-001-012024-07-30C16284748780-1f386c649-9a50-0266-e053-dadaa90a7c1a75% alcohol hand sanitizer
75690-001-012024-01-30C16284748780-1f386c649-9a50-0266-e053-dadaa90a7c1a75% alcohol hand sanitizer
75690-001-012023-02-13C16284748780-1f386c649-9a50-0266-e053-dadaa90a7c1a75% alcohol hand sanitizer
75690-001-012023-01-30C16284748780-1f386c649-9a50-0266-e053-dadaa90a7c1a75% alcohol hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75690-001-0175% alcohol hand sanitizer237 mL in 1 BOTTLEGEL2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75690-00175% ALCOHOL HAND SANITIZER (ALCOHOL) GEL [PINNACLE BRANDS LLC]4Legacy NDC, 1 package rows20230214_a3c8d061-cb70-867b-e053-2a95a90a07d4.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
75690-00175690-001-01
74621-001

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
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT

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
f48f6b74-edb0-98cb-e053-2a95a90a5c7ba3c8d061-cb70-867b-e053-2a95a90a07d42023-02-13WarningsExact identifier
spl id: f48f6b74-edb0-98cb-e053-2a95a90a5c7b
spl set id: a3c8d061-cb70-867b-e053-2a95a90a07d4

Reported adverse events (FAERS/openFDA)#

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