FDA.reportPublic FDA data

Ultra Defense Sani Smart Moisturizing Lotion & Sanitizer Spray

Manufacturer
K7 Design Group Inc.
Effective date
2020-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:38

Label at a glance#

ProductUltra Defense Sani Smart Moisturizing and Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

to decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

Spray directly on hands and rub in thoroughly For children under 6, use adult supervision Not recommended for infants

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 69% v/v

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

Flammable, keep away from fire or 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 and redness develop and persist for more than 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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray directly on hands and rub in thoroughly
  • For children under 6, use adult supervision
  • Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Fragrance, Denatonium Benzoate.

Company Information

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR & DISTRIBUTED BY K7 DESIGN GROUP LLC. 2433 KNAPP STREET, BROOKLYN, NY 11235

ORIGIN: CHINA

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kit1kit1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2377233ethanol 69 % Topical SprayPSN1
2377233ethanol 0.69 ML/ML Topical SpraySCD1
2377233ethanol 69 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74177-955-012022-01-28C16284748780-1d6a99b39-978c-a426-e053-dadaa90af4c2Ultra Defense Sani Smart Moisturizing Lotion & Sanitizer Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74177-954-01Ultra Defense Sani Smart Moisturizing and Sanitizer100 mL in 1 BOTTLE, SPRAYSPRAY100 mL69 mL in 100mL1
74177-955-01Ultra Defense Sani Smart Moisturizing and Sanitizer1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74177-954ULTRA DEFENSE SANI SMART MOISTURIZING AND SANITIZER (ALCOHOL) KIT [K7 DESIGN GROUP INC.]1Legacy NDC20201030_b2d2bd92-615d-2cc8-e053-2a95a90a63e6.zip
74177-955ULTRA DEFENSE SANI SMART MOISTURIZING AND SANITIZER (ALCOHOL) KIT [K7 DESIGN GROUP INC.]1Legacy NDC, 2 package rows20201030_b2d2bd92-615d-2cc8-e053-2a95a90a63e6.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74177-95574177-955-01
74177-95474177-954-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
PEG-100 STEARATEYD01N1999RINGR
DIMETHICONE92RU3N3Y1OINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR
ETHYLHEXYL PALMITATE2865993309INGR
PHENOXYETHANOLHIE492ZZ3TINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
POLYACRYLIC ACID (8000 MW)73861X4K5FINGR
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
CAPRYLYL GLYCOL00YIU5438UINGR
POTASSIUM HYDROXIDEWZH3C48M4TINGR
EDETATE DISODIUM7FLD91C86KINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
MINERAL OILT5L8T28FGPINGR

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
b2d2fd32-ab1f-a675-e053-2a95a90aef94b2d2bd92-615d-2cc8-e053-2a95a90a63e62020-10-29WarningsExact identifier
spl id: b2d2fd32-ab1f-a675-e053-2a95a90aef94
spl set id: b2d2bd92-615d-2cc8-e053-2a95a90a63e6

Reported adverse events (FAERS/openFDA)#

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