FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD
Effective date
2020-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:32

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria on skin.

Dosage and administration

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 106°F.(41°C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70.0%

​Purpose

OTC - PURPOSE SECTION

Antimicrobial

​Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin.

WARNINGS

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children. if swallowed,get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

Store below 106°F.(41°C)

May discolor certain fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua(Water),Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Parfum(Fragrance),

Aminomethyl Propanol,Aloe Barbadensis Leaf Extract.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ml label30 ml label60 ml label60 ml label100 ml label100 ml label250 ml label250 ml label500 ml label500 ml label1000 ml label1000 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69964-0011-12022-01-28C16284748780-1d6a99b39-d7b9-a426-e053-dadaa90af4c2HAND SANITIZER
69964-0011-22022-01-28C16284748780-1d6a99b39-d7b9-a426-e053-dadaa90af4c2HAND SANITIZER
69964-0011-32022-01-28C16284748780-1d6a99b39-d7b9-a426-e053-dadaa90af4c2HAND SANITIZER
69964-0011-42022-01-28C16284748780-1d6a99b39-d7b9-a426-e053-dadaa90af4c2HAND SANITIZER
69964-0011-52022-01-28C16284748780-1d6a99b39-d7b9-a426-e053-dadaa90af4c2HAND SANITIZER
69964-0011-62022-01-28C16284748780-1d6a99b39-d7b9-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69964-0011-1Hand Sanitizer30 mL in 1 BOTTLEGEL301
69964-0011-2Hand Sanitizer60 mL in 1 BOTTLEGEL601
69964-0011-3Hand Sanitizer100 mL in 1 BOTTLEGEL1001
69964-0011-4Hand Sanitizer250 mL in 1 BOTTLEGEL2501
69964-0011-5Hand Sanitizer500 mL in 1 BOTTLEGEL5001
69964-0011-6Hand Sanitizer1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69964-0011HAND SANITIZER GEL [XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD]1Legacy NDC, 6 package rows20200505_a337d923-fac8-9d95-e053-2995a90aa5b1.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
69964-001169964-0011-1, 69964-0011-2, 69964-0011-3, 69964-0011-4, 69964-0011-5, 69964-0011-6

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
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
a337db3b-8a96-e3de-e053-2a95a90a5836a337d923-fac8-9d95-e053-2995a90aa5b12020-04-13WarningsExact identifier
spl id: a337db3b-8a96-e3de-e053-2a95a90a5836
spl set id: a337d923-fac8-9d95-e053-2995a90aa5b1

Reported adverse events (FAERS/openFDA)#

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