FDA.reportPublic FDA data

Alcohol hand sanitizer

Manufacturer
Shantou Shengmei Biotechnology Co., Ltd.
Effective date
2020-04-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:06:48

Label at a glance#

ProductAlcohol hand sanitizer
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin. Recommend for repeated use.

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

OTC - WHEN USING SECTION

Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation develop, persisit for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children. If sallowed, get medical help right away.

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover hands and rub hands quickly until dry. Children under 6 years of age should be supervised when using product.

OTHER SAFETY INFORMATION

Do not store above 105F (43F). May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT SECTION

Aqua, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe Barbadensis Leaf Juice Powder, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55450-005-01 100g

PDPPDP

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
55450-005-012022-01-28C16284748780-1d6a99b39-f0cb-a426-e053-dadaa90af4c2Alcohol hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55450-005-01Alcohol hand sanitizer100 g in 1 BOTTLEGEL1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55450-005ALCOHOL HAND SANITIZER (HAND SANITIZER) GEL [SHANTOU SHENGMEI BIOTECHNOLOGY CO., LTD.]2Legacy NDC, 1 package rows20200418_a382319f-7d8f-0a61-e053-2995a90a2fa4.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
55450-00555450-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MACTIB
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
a382b4f5-77d4-ef10-e053-2a95a90ad43da382319f-7d8f-0a61-e053-2995a90a2fa42020-04-17WarningsExact identifier
spl id: a382b4f5-77d4-ef10-e053-2a95a90ad43d
spl set id: a382319f-7d8f-0a61-e053-2995a90a2fa4

Reported adverse events (FAERS/openFDA)#

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