FDA.reportPublic FDA data

Hand Sanitizer GEL

Manufacturer
Sanlingyi(Guangdong)Medical Biotechnology Co.,Ltd.
Effective date
2020-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:24

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 children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause 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 months of age on open skin wounds

WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product keep out of eyes,ears,and mouth.In case of contact with eyes,rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.Keep out of reach of children.If swallowed,get medical help or contact a Poison Control Center right away.

OTC-STOP USE SECTION

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed,get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

Store between 15-30C(59-86F)

Avoid freezing and excessive heat above 40C(104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol、Glycerin、Trolamine、Polyacrylic acid

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3 ml -5000L label3 ml -5000L label

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
78351-001-012021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-022021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-032021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-042021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-052021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-062021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-072021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-082021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-092021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-102021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-112021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-122021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-132021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL
78351-001-142021-07-23C16284748780-1c7ccaba7-29b5-fd44-e053-dadaa90aa01bHand Sanitizer GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78351-001-01Hand Sanitizer3 mL in 1 BOTTLEGEL31
78351-001-02Hand Sanitizer30 mL in 1 BOTTLEGEL301
78351-001-03Hand Sanitizer50 mL in 1 BOTTLEGEL501
78351-001-04Hand Sanitizer60 mL in 1 BOTTLEGEL601
78351-001-05Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78351-001-06Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78351-001-07Hand Sanitizer275 mL in 1 BOTTLEGEL2751
78351-001-08Hand Sanitizer300 mL in 1 BOTTLEGEL3001
78351-001-09Hand Sanitizer375 mL in 1 BOTTLEGEL3751
78351-001-10Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78351-001-11Hand Sanitizer580 mL in 1 BOTTLEGEL5801
78351-001-12Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
78351-001-13Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
78351-001-14Hand Sanitizer5000000 mL in 1 BOTTLEGEL50000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78351-001HAND SANITIZER GEL [SANLINGYI(GUANGDONG)MEDICAL BIOTECHNOLOGY CO.,LTD.]1Legacy NDC, 14 package rows20200523_a64e4f9b-2d06-e113-e053-2995a90aa7d5.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
78351-00178351-001-01, 78351-001-02, 78351-001-03, 78351-001-04, 78351-001-05, 78351-001-06, 78351-001-07, 78351-001-08, 78351-001-09, 78351-001-10, 78351-001-11, 78351-001-12, 78351-001-13, 78351-001-14

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
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
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
a64e4f9b-2d07-e113-e053-2995a90aa7d5a64e4f9b-2d06-e113-e053-2995a90aa7d52020-05-17WarningsExact identifier
spl id: a64e4f9b-2d07-e113-e053-2995a90aa7d5
spl set id: a64e4f9b-2d06-e113-e053-2995a90aa7d5