FDA.reportPublic FDA data

XtraCare Instand Hand Sanitizer

Manufacturer
China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2019-09-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:00:27

Label at a glance#

ProductXtraCare Instand Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

PURPOSE

Antimicrobial

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70%

INDICATIONS & USAGE SECTION

USAGE

For handwashing to decrease bacteria on the skin. Recommended for repeated use

DOSAGE & ADMINISTRATION SECTION

Directions

Wet hands thoroughly with product

Briskly rub hands together until dry

supervise children under six years in the use of this product

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.

Avoid contact with eyes. If this occurs, flush thoroughly with water.

WARNINGS SECTION

Warnings


For external use only

Flammable keep away from heat and flame

Do not use in the eye. in case of contact rinse thoroughly with water.

Stop use and ask doctor if irritation and redness develops and persist for more than 72 hours

INACTIVE INGREDIENT SECTION

WATER, CARBOMER, TOCOPHEROL ACETATE, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF JUICE, TRIETHANOLAMINE, GLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-090-012024-01-30C16284748780-11030e365-5812-111a-e063-dadaa90a10e2XtraCare Instand Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-090-01XtraCare Instand Hand Sanitizer59 mL in 1 BOTTLELIQUID593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-090XTRACARE INSTAND HAND SANITIZER (ETHYL ALCOHOL) LIQUID [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3Legacy NDC, 1 package rows20190918_4d75fcbc-7fcf-6884-e054-00144ff8d46c.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
58503-09058503-090-01

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
92d43245-94b7-f00e-e053-2a95a90a29a64d75fcbc-7fcf-6884-e054-00144ff8d46c2019-09-18WarningsExact identifier
spl id: 92d43245-94b7-f00e-e053-2a95a90a29a6
spl set id: 4d75fcbc-7fcf-6884-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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