FDA.reportPublic FDA data

Assured Instant Hand Sanitizer Lemon

Manufacturer
Greenbrier International | China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2018-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:27

Label at a glance#

ProductAssured Instant Hand Sanitizer Lemon 2 pk
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70.0%

OTC - PURPOSE SECTION

Antimicrobial

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

INDICATIONS & USAGE SECTION

Use:

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

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, tocopheryl acetate (Vitamin E), fd&c yellow no. 5.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxboxlabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-3032-22024-01-30C16284748780-11030e365-1c58-111a-e063-dadaa90a10e2Assured Instant Hand Sanitizer Lemon 2 fl oz. 2 pk

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-3032-1Assured Instant Hand Sanitizer Lemon2 pk59.2 mL in 1 BOTTLEGEL59.21
33992-3032-2Assured Instant Hand Sanitizer Lemon2 pk2 in 1 BOXGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-3032ASSURED INSTANT HAND SANITIZER LEMON 2 PK (ETHYL ALCOHOL) GEL [GREENBRIER INTERNATIONAL]1Legacy NDC, 2 package rows20181201_7be336b5-3baf-4006-e053-2991aa0aa71e.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
33992-303233992-3032-1, 33992-3032-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
FD&C YELLOW NO. 5I753WB2F1MIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT

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
7be336b5-3bb0-4006-e053-2991aa0aa71e7be336b5-3baf-4006-e053-2991aa0aa71e2018-11-30WarningsExact identifier
spl id: 7be336b5-3bb0-4006-e053-2991aa0aa71e
spl set id: 7be336b5-3baf-4006-e053-2991aa0aa71e

Reported adverse events (FAERS/openFDA)#

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