Ultra Defense Sani Smart Hand Sanitizer

Manufacturer
Gold Orient International Limited
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:19

Label at a glance#

ProductUltra Defense Sani Smart Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

for hand washing to decrease bacteria on the skin only when water is not available.

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water(Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Sodium Hydroxide, Fragrance (Parfum)

Warning

WARNINGS SECTION

  • For External Use Only.
  • Flammable, keep away from fire and flames

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes.
  • if contact occurs, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop us and ask a doctor if

  • irritation and redness develop

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 4label 4label 3label 3label 2label 2labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51522-004-012022-01-28C16284748780-1d6a99b39-beea-a426-e053-dadaa90af4c2Ultra Defense Sani Smart Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51522-004-01Ultra Defense Sani Smart Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51522-004ULTRA DEFENSE SANI SMART HAND SANITIZER (ALCOHOL) GEL [GOLD ORIENT INTERNATIONAL LIMITED]1Legacy NDC, 1 package rows20200428_a4480f13-814d-168b-e053-2a95a90adc7b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51522-00451522-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a44824a5-b4b5-75c9-e053-2995a90a3a5aa4480f13-814d-168b-e053-2a95a90adc7b2020-04-27WarningsExact identifier
spl id: a44824a5-b4b5-75c9-e053-2995a90a3a5a
spl set id: a4480f13-814d-168b-e053-2a95a90adc7b

Reported adverse events (FAERS/openFDA)#

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