Hand Sanitizer

Manufacturer
Orazen Inc
Effective date
2020-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:35

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, ues only under adult supervision not recommended for infants

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

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 and flame.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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
71927-002-022022-01-28C16284748780-1d6a99b39-abec-a426-e053-dadaa90af4c2aa843c84-1ec3-07e9-e053-2995a90a1945

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-002-02Hand Sanitizer37 mL in 1 BOTTLE, PLASTICGEL371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-002HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]1Legacy NDC, 1 package rows20200716_aa843c84-1ec3-07e9-e053-2995a90a1945.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
71927-00271927-002-02

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
aa842131-6f39-0643-e053-2995a90a3d39aa843c84-1ec3-07e9-e053-2995a90a19452020-07-14WarningsExact identifier
spl id: aa842131-6f39-0643-e053-2995a90a3d39
spl set id: aa843c84-1ec3-07e9-e053-2995a90a1945

Reported adverse events (FAERS/openFDA)#

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