FDA.reportPublic FDA data

Assured Instant

Manufacturer
China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2019-09-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:00:28

Label at a glance#

ProductAssured Instant
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Ethyl Alcohol 70.0% v/v ............... Antimicrobial

OTC - PURPOSE SECTION

Uses

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

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.

INDICATIONS & USAGE SECTION

Instant Hand Sanitizer

Vitamin E and Moisturizers

Kills 99% of Germs!

Lavender Scented

Each: 2 fl oz (59.2 mL)

DOSAGE & ADMINISTRATION SECTION

Directions

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years on the use of this product

WARNINGS SECTION

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

INACTIVE INGREDIENT SECTION

Inactive ingredients water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate, d&c red no.33, fd&c blue no.1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-092-012024-01-30C16284748780-11030e365-255e-111a-e063-dadaa90a10e2HAND SANITIZER BOX 2Z 3PK (Lavender)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-092-01Assured Instant259 mL in 1 PACKAGEGEL2594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-092ASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]4Legacy NDC, 1 package rows20190918_4db1d1dc-a423-3842-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58503-09258503-092-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MACTIB

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
92d44bd6-be92-6134-e053-2995a90ad1204db1d1dc-a423-3842-e054-00144ff88e882019-09-18WarningsExact identifier
spl id: 92d44bd6-be92-6134-e053-2995a90ad120
spl set id: 4db1d1dc-a423-3842-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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