Hand Sanitizer

Manufacturer
Orazen Inc
Effective date
2017-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:22

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% w/w

OTC - PURPOSE SECTION

Purpose

Antiseptic

WARNINGS SECTION

Warnings

Flammable, keep away from fire or flame.

For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develops and persists for more that 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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Wet hands thoroughly with product
  • Briskly rub hands together until dry
  • Supervise children in the use of this product

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, carbomer, fragrance, triethanoamine, glycerin, propylene glycol, isopropyl alcohol, isopropyl myristate, tocopheryl acetate, aloe vera extract

OTHER SAFETY INFORMATION

Other Information

  • Store at room temperature 15 to 30C (59 to 86F)
  • May discolor certain fabrics

INDICATIONS & USAGE SECTION

Use

For hand washing to decrease bacteria on the skin

OTC - DO NOT USE SECTION

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of blister cardimage of blister cardimage 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
71927-001-012025-01-30C16284748780-12cef2736-91d1-d83d-e063-dadaa90ab31f600b618b-183a-18f6-e053-2a91aa0ae7ff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-001-01Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-001HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]1Current NDC, Legacy NDC, 1 package rows20171211_600b618b-183a-18f6-e053-2a91aa0ae7ff.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71927-00171927-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerETHYL ALCOHOLOrazen Incaa846bb7-a64b-3358-e053-2995a90a9d092025-04-07WarningsExact identifier
ndc (product): 71927-001
600b618b-183b-18f6-e053-2a91aa0ae7ff600b618b-183a-18f6-e053-2a91aa0ae7ff2017-12-10WarningsExact identifier
spl id: 600b618b-183b-18f6-e053-2a91aa0ae7ff
spl set id: 600b618b-183a-18f6-e053-2a91aa0ae7ff

Reported adverse events (FAERS/openFDA)#

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