FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD
Effective date
2020-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:48

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

69964-0013-6 60ml169964-0013-6 60ml169964-0013-8 250ml69964-0013-8 250ml69964-0013-7 100ml69964-0013-7 100ml69964-0013-9 500ml69964-0013-9 500ml69964-0013-6 60ml269964-0013-6 60ml269964-0013-3 1 ounce ONE TOYOTA169964-0013-3 1 ounce ONE TOYOTA169964-0013-5 1 ounce TOYOTA169964-0013-5 1 ounce TOYOTA169964-0013-4 1 ounce Lexus169964-0013-4 1 ounce Lexus169964-0013-1 1 ounce AIG FUNDS169964-0013-1 1 ounce AIG FUNDS169964-0013-5 1 ounce TOYOTA269964-0013-5 1 ounce TOYOTA269964-0013-2 1 ounce AIG269964-0013-2 1 ounce AIG269964-0013-4 1 ounce Lexus269964-0013-4 1 ounce Lexus269964-0013-1 1 ounce AIG FUNDS269964-0013-1 1 ounce AIG FUNDS269964-0013-3 1 ounce ONE TOYOTA269964-0013-3 1 ounce ONE TOYOTA269964-0013-2 1 ounce AIG169964-0013-2 1 ounce AIG1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69964-0013-12022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-22022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-32022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-42022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-52022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-62022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-72022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-82022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer
69964-0013-92022-01-28C16284748780-1d6a99b39-fa6e-a426-e053-dadaa90af4c269964-0013 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69964-0013-1Hand Sanitizer29.57 mL in 1 BOTTLEGEL29.572
69964-0013-2Hand Sanitizer29.57 mL in 1 BOTTLEGEL29.572
69964-0013-3Hand Sanitizer29.57 mL in 1 BOTTLEGEL29.572
69964-0013-4Hand Sanitizer29.57 mL in 1 BOTTLEGEL29.572
69964-0013-5Hand Sanitizer29.57 mL in 1 BOTTLEGEL29.572
69964-0013-6Hand Sanitizer60 mL in 1 BOTTLEGEL602
69964-0013-7Hand Sanitizer100 mL in 1 BOTTLEGEL1002
69964-0013-8Hand Sanitizer250 mL in 1 BOTTLEGEL2502
69964-0013-9Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69964-0013HAND SANITIZER GEL [XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD]2Legacy NDC, 9 package rows20200826_adaf7316-75a6-5417-e053-2995a90ad35b.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
69964-001369964-0013-1, 69964-0013-4, 69964-0013-2, 69964-0013-3, 69964-0013-5, 69964-0013-6, 69964-0013-7, 69964-0013-8, 69964-0013-9

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
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

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
adafdc21-de0a-15f6-e053-2995a90a4584adaf7316-75a6-5417-e053-2995a90ad35b2020-08-25WarningsExact identifier
spl id: adafdc21-de0a-15f6-e053-2995a90a4584
spl set id: adaf7316-75a6-5417-e053-2995a90ad35b

Reported adverse events (FAERS/openFDA)#

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