Ultra Defense Sani Smart Hibiscus Paradise

Manufacturer
Gold Orient International Limited
Effective date
2020-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:05

Label at a glance#

ProductUltra Defense Sani Smart Hibiscus Paradise
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Store at 68° to 77°F (20°~25°C) Do not store above 110°F (43°C) You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat. 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire and flames

When using this product

WARNINGS SECTION

do not get into eyes.

if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

WARNINGS SECTION

irritation and redness develop

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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Store at 68° to 77°F (20°~25°C)
  • Do not store above 110°F (43°C)
  • You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Aloe Barbadensis Leaf Extract, Polysorbate 20, Sodium Hydroxide, Red 33, Yellow 5, Blue 1.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
51522-051-012022-01-28C16284748780-1d6a99b39-4589-a426-e053-dadaa90af4c2Ultra Defense Sani Smart Hibiscus Paradise

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51522-051-01Ultra Defense Sani Smart Hibiscus Paradise236 mL in 1 BOTTLE, PLASTICGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51522-051ULTRA DEFENSE SANI SMART HIBISCUS PARADISE (ALCOHOL) GEL [GOLD ORIENT INTERNATIONAL LIMITED]1Legacy NDC, 1 package rows20200819_ac0fadf9-f445-6f3c-e053-2a95a90a245e.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
51522-05151522-051-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
ac0fadf9-f446-6f3c-e053-2a95a90a245eac0fadf9-f445-6f3c-e053-2a95a90a245e2020-08-04WarningsExact identifier
spl id: ac0fadf9-f446-6f3c-e053-2a95a90a245e
spl set id: ac0fadf9-f445-6f3c-e053-2a95a90a245e

Reported adverse events (FAERS/openFDA)#

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