FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Guangzhou caolvxiang Biotechnology Co.,Ltd
Effective date
2020-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:23

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces, Rub hands together until dry. Supervise clhildren under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that poterntially can cuase disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

in children less than 2 rnonths of age
on open skin worunds

WHEN USING SECTION

OTC - WHEN USING SECTION

keep out of eyes.ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.
These rnay be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed. get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces, Rub hands together until dry.
Supervise clhildren under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78414-002-012022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer
78414-002-022022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer
78414-002-032022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer
78414-002-042022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer
78414-002-052022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer
78414-002-062022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer
78414-002-072022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer
78414-002-082022-01-28C16284748780-1d6a99b39-76ac-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78414-002-01Hand Sanitizer30 mL in 1 BOTTLEGEL301
78414-002-02Hand Sanitizer50 mL in 1 BOTTLEGEL501
78414-002-03Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78414-002-04Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78414-002-05Hand Sanitizer350 mL in 1 BOTTLEGEL3501
78414-002-06Hand Sanitizer354 mL in 1 BOTTLEGEL3541
78414-002-07Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78414-002-08Hand Sanitizer1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78414-002HAND SANITIZER GEL [GUANGZHOU CAOLVXIANG BIOTECHNOLOGY CO.,LTD]1Legacy NDC, 8 package rows20200715_aa63a9fe-522e-63ec-e053-2995a90a8567.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78414-00278414-002-06, 78414-002-07, 78414-002-08, 78414-002-01, 78414-002-02, 78414-002-03, 78414-002-04, 78414-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
aa63ad83-f6e4-46c2-e053-2a95a90a409baa63a9fe-522e-63ec-e053-2995a90a85672020-07-14WarningsExact identifier
spl id: aa63ad83-f6e4-46c2-e053-2a95a90a409b
spl set id: aa63a9fe-522e-63ec-e053-2995a90a8567

Reported adverse events (FAERS/openFDA)#

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