FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Cit Co., Ltd.
Effective date
2022-02-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:48:17

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Hand sanitizer to help reduce bacteria on skin

Dosage and administration

• Put enough product in your palm to cover hands and rub hands together briskly until dry. • Children under 6 years of age should be supervised when using product.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 70% v/v

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water(Aqua), Glycerin, Carbomer, Aminomethyl Propanol

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

WARNINGS

WARNINGS SECTION

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

--------------------------------------------------------------------------------------------------------
Do not use
• in children less than 2 months of age
• on open skin wounds
--------------------------------------------------------------------------------------------------------
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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on skin

Directions

DOSAGE & ADMINISTRATION SECTION

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using product.

QUESTIONS?

OTC - QUESTIONS SECTION

+1-855-437-0104

Other information

OTHER SAFETY INFORMATION

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surfaces

Package Label: 69133-110-01 - HAND SANITIZER (300mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

Package Label: 69133-110-02 - HAND SANITIZER (500mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69133-110-012024-01-30C16284748780-1d6a99b39-4c97-a426-e053-dadaa90af4c2HAND SANITIZER
69133-110-022024-01-30C16284748780-1d6a99b39-4c97-a426-e053-dadaa90af4c2HAND SANITIZER
69133-110-012022-02-16C16284748780-1d6a99b39-4c97-a426-e053-dadaa90af4c2HAND SANITIZER
69133-110-022022-02-16C16284748780-1d6a99b39-4c97-a426-e053-dadaa90af4c2HAND SANITIZER
69133-110-012022-01-28C16284748780-1d6a99b39-4c97-a426-e053-dadaa90af4c2HAND SANITIZER
69133-110-022022-01-28C16284748780-1d6a99b39-4c97-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69133-110-01HAND SANITIZER300 mL in 1 BOTTLE, PUMPGEL3004
69133-110-02HAND SANITIZER500 mL in 1 BOTTLE, PUMPGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69133-110HAND SANITIZER (ETHYL ALCOHOL) GEL [CIT CO., LTD.]4Legacy NDC, 2 package rows20220217_830385cf-784a-4edc-b16b-b55d97a61a0c.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
69133-11069133-110-01, 69133-110-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
d81f1cea-5e9d-7aab-e053-2a95a90a574f830385cf-784a-4edc-b16b-b55d97a61a0c2022-02-16WarningsExact identifier
spl id: d81f1cea-5e9d-7aab-e053-2a95a90a574f
spl set id: 830385cf-784a-4edc-b16b-b55d97a61a0c

Reported adverse events (FAERS/openFDA)#

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