FDA.reportPublic FDA data

the SAEM Clean Everyday Hand Sanitizer gel

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

Label at a glance#

Productthe SAEM Clean Everyday Hand Sanitizer gel
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

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

Storage and handling

Store below 110°F (43°C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Dipropylene Glycol, Carbomer, Glycerin, Triethanolamine, PEG-60 Hydrogenated Caster Oil, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Diethanolamine, Citrus Paradisi (Grapefruit) Peel Oil, Sodium Hyaluronate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct 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
70341-001-012021-07-23C16284748780-1c7ccaba7-1383-fd44-e053-dadaa90aa01b70341-001_the SAEM Clean Everyday Hand Sanitizer Gel
70341-001-022021-07-23C16284748780-1c7ccaba7-1383-fd44-e053-dadaa90aa01b70341-001_the SAEM Clean Everyday Hand Sanitizer Gel
70341-001-032021-07-23C16284748780-1c7ccaba7-1383-fd44-e053-dadaa90aa01b70341-001_the SAEM Clean Everyday Hand Sanitizer Gel
70341-001-042021-07-23C16284748780-1c7ccaba7-1383-fd44-e053-dadaa90aa01b70341-001_the SAEM Clean Everyday Hand Sanitizer Gel
70341-001-052021-07-23C16284748780-1c7ccaba7-1383-fd44-e053-dadaa90aa01b70341-001_the SAEM Clean Everyday Hand Sanitizer Gel
70341-001-062021-07-23C16284748780-1c7ccaba7-1383-fd44-e053-dadaa90aa01b70341-001_the SAEM Clean Everyday Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70341-001-01the SAEM Clean Everyday Hand Sanitizer gel30 mL in 1 BOTTLEGEL301
70341-001-02the SAEM Clean Everyday Hand Sanitizer gel60 mL in 1 BOTTLEGEL601
70341-001-03the SAEM Clean Everyday Hand Sanitizer gel100 mL in 1 TUBEGEL1001
70341-001-04the SAEM Clean Everyday Hand Sanitizer gel250 mL in 1 BOTTLE, PUMPGEL2501
70341-001-05the SAEM Clean Everyday Hand Sanitizer gel300 mL in 1 BOTTLEGEL3001
70341-001-06the SAEM Clean Everyday Hand Sanitizer gel500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70341-001THE SAEM CLEAN EVERYDAY HAND SANITIZER GEL (ALCOHOL) GEL [THE SAEM INTERNATIONAL CO., LTD.]1Legacy NDC, 6 package rows20200414_313dbaff-1d22-4899-ba9d-dd2be1b8e86d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70341-00170341-001-01, 70341-001-02, 70341-001-03, 70341-001-04, 70341-001-05, 70341-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
PANTHENOLWV9CM0O67ZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT
DIETHANOLAMINEAZE05TDV2VIACT
GRAPEFRUIT OILYR377U58W9IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
a333af10-8303-ce78-e053-2995a90afb0d313dbaff-1d22-4899-ba9d-dd2be1b8e86d2020-04-13WarningsExact identifier
spl id: a333af10-8303-ce78-e053-2995a90afb0d
spl set id: 313dbaff-1d22-4899-ba9d-dd2be1b8e86d

Reported adverse events (FAERS/openFDA)#

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