FDA.reportPublic FDA data

Pro Clean Instant Hand Sanitizer

Manufacturer
Sistemas de Sanitazion y Fragancias Avanzados S.A.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:37

Label at a glance#

ProductPro Clean Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

To help reduce bacteria and germs on the skin that potentially can cuase disease. Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in eyes, in case of contact rinse eyes thoroughly with water
  • in children less than 2 months of age
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 20-25C (68-77F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, carbomer, triethanolamine, glycerin.

Package Labeling:29ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:59ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:236ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling:295ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Package Labeling:473ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

Package Labeling:3785ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

updated 1 gallon labelupdated 1 gallon label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80570-001-012023-01-30C16284748780-1f386c649-dad0-0266-e053-dadaa90a7c1aPro Clean Instant Hand Sanitizer
80570-001-022023-01-30C16284748780-1f386c649-dad0-0266-e053-dadaa90a7c1aPro Clean Instant Hand Sanitizer
80570-001-032023-01-30C16284748780-1f386c649-dad0-0266-e053-dadaa90a7c1aPro Clean Instant Hand Sanitizer
80570-001-042023-01-30C16284748780-1f386c649-dad0-0266-e053-dadaa90a7c1aPro Clean Instant Hand Sanitizer
80570-001-052023-01-30C16284748780-1f386c649-dad0-0266-e053-dadaa90a7c1aPro Clean Instant Hand Sanitizer
80570-001-062023-01-30C16284748780-1f386c649-dad0-0266-e053-dadaa90a7c1aPro Clean Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80570-001-01Pro Clean Instant Hand Sanitizer29 mL in 1 BOTTLELIQUID291
80570-001-02Pro Clean Instant Hand Sanitizer59 mL in 1 BOTTLELIQUID591
80570-001-03Pro Clean Instant Hand Sanitizer236 mL in 1 BOTTLELIQUID2361
80570-001-04Pro Clean Instant Hand Sanitizer295 mL in 1 BOTTLELIQUID2951
80570-001-05Pro Clean Instant Hand Sanitizer473 mL in 1 BOTTLELIQUID4731
80570-001-06Pro Clean Instant Hand Sanitizer3785 mL in 1 BOTTLELIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80570-001PRO CLEAN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [SISTEMAS DE SANITAZION Y FRAGANCIAS AVANZADOS S.A.]1Legacy NDC, 6 package rows20201205_b57e668f-cdc1-4103-e053-2a95a90a3dce.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
80570-00180570-001-01, 80570-001-02, 80570-001-03, 80570-001-04, 80570-001-05, 80570-001-06

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
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
b57e52aa-ed4c-63a8-e053-2a95a90a6e75b57e668f-cdc1-4103-e053-2a95a90a3dce2020-12-02WarningsExact identifier
spl id: b57e52aa-ed4c-63a8-e053-2a95a90a6e75
spl set id: b57e668f-cdc1-4103-e053-2a95a90a3dce

Reported adverse events (FAERS/openFDA)#

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