Hand Sanitizer

Manufacturer
Orazen Inc
Effective date
2019-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient:
Ethyl alcohol 62%

OTC - PURPOSE SECTION

Purpose

Antiseptic

WARNINGS SECTION

Warnings

For external use only: hands

Flammable. Keep away from fire and flame.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more than 72 hours

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(1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, ues only under adult supervision
  • not recommended for infants

INACTIVE INGREDIENT SECTION

Inactive ingredients

acrylates/C10-C30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, triethanolamine, water

OTHER SAFETY INFORMATION

Other Information

  • do not store above 105F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

INDICATIONS & USAGE SECTION

Uses to decrease bacteria on the skin that could cause disease. recommended for repeated use

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71927-007-012025-01-30C16284748780-12cef2736-964a-d83d-e063-dadaa90ab31f98b90d27-eb53-3c45-e053-2995a90ab0b3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-007-01Hand Sanitizer236.58 mL in 1 BOTTLE, PLASTICGEL236.581

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-007HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]1Legacy NDC, 1 package rows20191204_98b90d27-eb53-3c45-e053-2995a90ab0b3.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71927-00771927-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
98b90d27-eb54-3c45-e053-2995a90ab0b398b90d27-eb53-3c45-e053-2995a90ab0b32019-12-02WarningsExact identifier
spl id: 98b90d27-eb54-3c45-e053-2995a90ab0b3
spl set id: 98b90d27-eb53-3c45-e053-2995a90ab0b3

Reported adverse events (FAERS/openFDA)#

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