FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:08

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

● Apply as needed into palm of hand and thoroughly spread on both hands, rub until dry. ● Supervise children under 6 years of age when using this product.

Storage and handling

● Store between15-30°c(59-86°F) ● Avoid freezing and excessive heat above40°c(104°F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70.0%V/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not avaliable.

Warnings

WARNINGS SECTION

For external use only
Flammable, keep away from heat and flame.

Do not use

OTC - DO NOT USE SECTION

● on infants
● on open skin wounds

OTC - WHEN USING SECTION

/

OTC - STOP USE SECTION

Stop use, and ask a doctor if irritation and redness develop and persistfor more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

● Apply as needed into palm of hand and thoroughly spread on both hands, rub until dry.
● Supervise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

● Store between15-30°c(59-86°F)
● Avoid freezing and excessive heat above40°c(104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized water, Triethanolamine, Carbomer,Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocophe Acetate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

66

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-803-012024-01-30C16284748780-11030e364-f94e-111a-e063-dadaa90a10e2Hand Sanitizer
58503-803-022024-01-30C16284748780-11030e364-f94e-111a-e063-dadaa90a10e2Hand Sanitizer
58503-803-032024-01-30C16284748780-11030e364-f94e-111a-e063-dadaa90a10e2Hand Sanitizer
58503-803-042024-01-30C16284748780-11030e364-f94e-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-803-01Hand Sanitizer60 mL in 1 BOTTLEGEL601
58503-803-02Hand Sanitizer237 mL in 1 BOTTLEGEL2371
58503-803-03Hand Sanitizer500 mL in 1 BOTTLEGEL5001
58503-803-04Hand Sanitizer3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-803HAND SANITIZER GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1Legacy NDC, 4 package rows20200611_a7b86322-5a4d-15d7-e053-2a95a90a5d33.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58503-80358503-803-01, 58503-803-02, 58503-803-03, 58503-803-04

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
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL SUCCINATE, D-LU4B53JYVEIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
a7b86322-5a4c-15d7-e053-2a95a90a5d33a7b86322-5a4d-15d7-e053-2a95a90a5d332020-06-10WarningsExact identifier
spl id: a7b86322-5a4c-15d7-e053-2a95a90a5d33
spl set id: a7b86322-5a4d-15d7-e053-2a95a90a5d33

Reported adverse events (FAERS/openFDA)#

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