FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Jinhua City Wellmae Cosmetics Co., Ltd.
Effective date
2022-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:13

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 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

ETHYL ALCOHOL 75% V/V

Use

INDICATIONS & USAGE SECTION

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTILLY CAN CAUSE DISEASE, FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

Do not use

OTC - DO NOT USE SECTION

●ON CHILDREN LESS THAN 2 MONTHS OF AGE

●ON OPEN SKIN WOUNDS

OTC - WHEN USING SECTION

KEEP OUT OF EYES, EARS AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

OTC - STOP USE SECTION

IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

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

PURIFIED WATER, PROPYLENE GLYCOL, GLYCERIN, CARBOMER, TRIETHANOLAMINE

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5005006060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75427-006-012024-01-30C16284748780-10191ceaa-68fc-198a-e063-dbdaa90aec3e75427-006 Hand Sanitizer
75427-006-022024-01-30C16284748780-10191ceaa-68fc-198a-e063-dbdaa90aec3e75427-006 Hand Sanitizer
75427-006-012023-11-09C16284748780-10191ceaa-68fc-198a-e063-dbdaa90aec3e75427-006 Hand Sanitizer
75427-006-022023-11-09C16284748780-10191ceaa-68fc-198a-e063-dbdaa90aec3e75427-006 Hand Sanitizer
75427-006-012023-07-28C16284748780-10191ceaa-68fc-198a-e063-dbdaa90aec3e75427-006 Hand Sanitizer
75427-006-022023-07-28C16284748780-10191ceaa-68fc-198a-e063-dbdaa90aec3e75427-006 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75427-006-01Hand Sanitizer60 mL in 1 BOTTLEGEL602
75427-006-02Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75427-006HAND SANITIZER (ALCOHOL) GEL [JINHUA CITY WELLMAE COSMETICS CO., LTD.]2Legacy NDC, 2 package rows20220120_a7b5cf19-5389-3b34-e053-2995a90a210b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75427-00675427-006-01, 75427-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
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
d5fbcd1b-090a-8db2-e053-2a95a90a47fba7b5cf19-5389-3b34-e053-2995a90a210b2022-01-19WarningsExact identifier
spl id: d5fbcd1b-090a-8db2-e053-2a95a90a47fb
spl set id: a7b5cf19-5389-3b34-e053-2995a90a210b

Reported adverse events (FAERS/openFDA)#

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