FDA.reportPublic FDA data

Ultra Defense Sani Smart 2pk Hand Sanitizer

Manufacturer
K7 Design Group Inc.
Effective date
2020-11-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:13

Label at a glance#

ProductUltra Defense Sani Smart 2pk Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 69% v/v

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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Raspberry

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Blue 1, Red 33.

Strawberry

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Red 33.

Company Information

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC. NEW YORK, NY 10016

ORIGIN: CHINA

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

strawberrystrawberryraspberryraspberry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287763ethanol 69 % Topical GelPSN1
2287763ethanol 0.69 ML/ML Topical GelSCD1
2287763ethanol 69 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74177-987-012022-01-28C16284748780-1d6a99b39-7ff4-a426-e053-dadaa90af4c2Ultra Defense Sani Smart 2pk Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74177-987-01Ultra Defense Sani Smart 2pk Hand Sanitizer1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74177-987ULTRA DEFENSE SANI SMART 2PK HAND SANITIZER (ALCOHOL) KIT [K7 DESIGN GROUP INC.]1Legacy NDC, 1 package rows20201125_b4daeead-ebe2-8140-e053-2995a90ae86f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74177-98774177-987-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
D&C RED NO. 339DBA0SBB0LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
D&C RED NO. 339DBA0SBB0LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
b4dac9e3-3340-d42f-e053-2995a90aaf14b4daeead-ebe2-8140-e053-2995a90ae86f2020-11-24WarningsExact identifier
spl id: b4dac9e3-3340-d42f-e053-2995a90aaf14
spl set id: b4daeead-ebe2-8140-e053-2995a90ae86f

Reported adverse events (FAERS/openFDA)#

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