Hand Sanitizer

Manufacturer
reBom Co., Ltd.
Effective date
2020-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:08

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

■ Place enough product on your hands to cover all surfaces. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to aviod swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help decrease bacteria on the skin. For use when soap and water are not available.

Do not use

OTC - DO NOT USE SECTION

■ In children less than 2 months of age

■ on open skin wounds

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

Keep out of eyes ears an mouth . In case of eye contact immediately flush eyes throughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Place enough product on your hands to cover all surfaces. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to aviod swallowing.

Other information

SPL UNCLASSIFIED SECTION

■ Store between 15º-30ºC (59º-89ºF) ■ Avoid freezing and excessive heat above 40ºC (140ºF) ■ May discolor fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer, glycerin, triethanolamine, water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage 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
60604-010-162022-01-28C16284748780-1d6a99b39-bcb8-a426-e053-dadaa90af4c2reBom Hand Sanitizer
60604-010-372022-01-28C16284748780-1d6a99b39-bcb8-a426-e053-dadaa90af4c2reBom Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60604-010-16Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
60604-010-37Hand Sanitizer110 mL in 1 BOTTLE, PLASTICGEL1101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60604-010HAND SANITIZER (ALCOHOL) GEL [REBOM CO., LTD.]1Legacy NDC, 2 package rows20200414_a2cda367-14f4-b2ff-e053-2995a90a1f34.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60604-01060604-010-16, 60604-010-37

Ingredients#

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

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

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
a2cd9df2-a81f-3f23-e053-2a95a90a7b95a2cda367-14f4-b2ff-e053-2995a90a1f342020-04-13WarningsExact identifier
spl id: a2cd9df2-a81f-3f23-e053-2a95a90a7b95
spl set id: a2cda367-14f4-b2ff-e053-2995a90a1f34

Reported adverse events (FAERS/openFDA)#

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