FDA.reportPublic FDA data

KLEEN HAND SANITIZER

Manufacturer
79741 | SAIGON COSMETICS CORPORATION
Effective date
2020-08-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:25:46

Label at a glance#

ProductKLEEN HAND SANITIZER
Active ingredientALCOHOL
Label structure13 sections

Storage and handling

Other information: Store between 15-25oC (59-77oF) Avoid freezing and excessive heat above 40oC (104oF)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v Purpose: Antiseptic

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE SECTION

Hand sanitizer to help decrease bacteria that can potentially cause disease. For use when soap and water are not available.

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • In children without aldult supervision
  • On open skin wound

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious conditions.

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

· Place enough product on hands to cover all surfaces. Rub hands together until dry.

· Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING SECTION

Other information:

  • Store between 15-25oC (59-77oF)
  • Avoid freezing and excessive heat above 40oC (104oF)

INACTIVE INGREDIENT SECTION

Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked), Propylene Glycol, Trolamine, Water

OTC - QUESTIONS SECTION

+84-28-3742-1102

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kleen Hand Sanitizer 90mL

(Label) Kleen Hand Sanitizer 90mL(Label) Kleen Hand Sanitizer 90mL

Kleen Hand Sanitizer 100mL

(Label) Kleen Hand Sanitizer 100ml(Label) Kleen Hand Sanitizer 100ml

Kleen Hand Sanitizer 250mL

(Label) Kleen Hand Sanitizer 250 mL(Label) Kleen Hand Sanitizer 250 mLKleen Hand Sanitizer 320mL

(Label) Kleen Hand Sanitizer 320ml(Label) Kleen Hand Sanitizer 320ml

Kleen Hand Sanitizer 500mL

(Label) Kleen Hand Sanitizer 500ml(Label) Kleen Hand Sanitizer 500ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN5
581662ethanol 0.7 ML/ML Topical GelSCD5
581662ethanol 70 % Topical GelSY5
581662ethyl alcohol 70 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79741-000-092022-01-28C16284748780-1d6a99b39-e0d1-a426-e053-dadaa90af4c2aba50897-3c2c-bd64-e053-2995a90a2a2b
79741-000-102022-01-28C16284748780-1d6a99b39-e0d1-a426-e053-dadaa90af4c2aba50897-3c2c-bd64-e053-2995a90a2a2b
79741-000-252022-01-28C16284748780-1d6a99b39-e0d1-a426-e053-dadaa90af4c2aba50897-3c2c-bd64-e053-2995a90a2a2b
79741-000-322022-01-28C16284748780-1d6a99b39-e0d1-a426-e053-dadaa90af4c2aba50897-3c2c-bd64-e053-2995a90a2a2b
79741-000-502022-01-28C16284748780-1d6a99b39-e0d1-a426-e053-dadaa90af4c2aba50897-3c2c-bd64-e053-2995a90a2a2b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79741-000-09KLEEN HAND SANITIZER90 mL in 1 BOTTLE, PLASTICGEL905
79741-000-10KLEEN HAND SANITIZER100 mL in 1 BOTTLE, PLASTICGEL1005
79741-000-25KLEEN HAND SANITIZER250 mL in 1 BOTTLE, PUMPGEL2505
79741-000-32KLEEN HAND SANITIZER320 mL in 1 BOTTLE, PUMPGEL3205
79741-000-50KLEEN HAND SANITIZER500 mL in 1 BOTTLE, PUMPGEL5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79741-000KLEEN HAND SANITIZER (ALCOHOL) GEL [79741]5Legacy NDC, 5 package rows20200826_aba50897-3c2c-bd64-e053-2995a90a2a2b.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
79741-00079741-000-50, 79741-000-32, 79741-000-10, 79741-000-09, 79741-000-25

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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
adafc363-e521-d60e-e053-2a95a90a0edcaba50897-3c2c-bd64-e053-2995a90a2a2b2020-08-25WarningsExact identifier
spl id: adafc363-e521-d60e-e053-2a95a90a0edc
spl set id: aba50897-3c2c-bd64-e053-2995a90a2a2b

Reported adverse events (FAERS/openFDA)#

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