FDA.reportPublic FDA data

Ultra Defense Sani Smart 15 PK 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 23:08:20

Label at a glance#

ProductUltra Defense Sani Smart 15 PK Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thorough;y with product and allow to dry without wiping

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat. 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to decrease bacteria on the skin, only when water is not available.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thorough;y with product and allow to dry without wiping

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Polysorbate 20, Sodium Hydroxide

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51522-005-012022-01-28C16284748780-1d6a99b39-d86f-a426-e053-dadaa90af4c2a44b7955-7a5f-217b-e053-2a95a90ae0c7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51522-005-01Ultra Defense Sani Smart 15 PK Hand Sanitizer1 in 1 JARGEL11
51522-005-01Ultra Defense Sani Smart 15 PK Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51522-005ULTRA DEFENSE SANI SMART 15 PK HAND SANITIZER (ALCOHOL) GEL [GOLD ORIENT INTERNATIONAL LIMITED]1Legacy NDC, 2 package rows20200428_a44b7955-7a5f-217b-e053-2a95a90ae0c7.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
51522-00551522-005-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a44b7955-7a4f-217b-e053-2a95a90ae0c7a44b7955-7a5f-217b-e053-2a95a90ae0c72020-04-27WarningsExact identifier
spl id: a44b7955-7a4f-217b-e053-2a95a90ae0c7
spl set id: a44b7955-7a5f-217b-e053-2a95a90ae0c7

Reported adverse events (FAERS/openFDA)#

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