FDA.reportPublic FDA data

Pureza Advanced Hand Sanitizer

Manufacturer
Industrias Coramodio C.A
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:20

Label at a glance#

ProductPureza Advanced Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease  Recommended for repeated use

Dosage and administration

• Place enough product in your palm to thoroughly cover your hands • Rub hands together briskly until dry • No rinsing required • No towels needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease 
  • Recommended for repeated use

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes throroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash appears os ojos con agua. and lasts

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 in your palm to thoroughly cover your hands • Rub hands together briskly until dry • No rinsing required • No towels needed

Other information

SPL UNCLASSIFIED SECTION

• Store below 110ºF (43ºC)
• May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Water, Isopropyl Alcohol, Glycerin, Carbomer, Triethanolamine, Fragance.

Package Labeling:80ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:200ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

Package Labeling:3780ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

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
81182-000-012023-01-30C16284748780-1f386c64a-0e89-0266-e053-dadaa90a7c1aPureza Advanced Hand Sanitizer
81182-000-022023-01-30C16284748780-1f386c64a-0e89-0266-e053-dadaa90a7c1aPureza Advanced Hand Sanitizer
81182-000-032023-01-30C16284748780-1f386c64a-0e89-0266-e053-dadaa90a7c1aPureza Advanced Hand Sanitizer
81182-000-042023-01-30C16284748780-1f386c64a-0e89-0266-e053-dadaa90a7c1aPureza Advanced Hand Sanitizer
81182-000-052023-01-30C16284748780-1f386c64a-0e89-0266-e053-dadaa90a7c1aPureza Advanced Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81182-000-01Pureza Advanced Hand Sanitizer80 mL in 1 BOTTLEGEL801
81182-000-02Pureza Advanced Hand Sanitizer200 mL in 1 BOTTLEGEL2001
81182-000-03Pureza Advanced Hand Sanitizer500 mL in 1 BOTTLEGEL5001
81182-000-04Pureza Advanced Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
81182-000-05Pureza Advanced Hand Sanitizer3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81182-000PUREZA ADVANCED HAND SANITIZER (ALCOHOL) GEL [INDUSTRIAS CORAMODIO C.A]1Legacy NDC, 5 package rows20210101_b5e664be-9f29-53df-e053-2995a90ad4d6.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
81182-00081182-000-01, 81182-000-02, 81182-000-03, 81182-000-04, 81182-000-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
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
b5e6820c-9e22-0d80-e053-2a95a90a23f8b5e664be-9f29-53df-e053-2995a90ad4d62020-12-07WarningsExact identifier
spl id: b5e6820c-9e22-0d80-e053-2a95a90a23f8
spl set id: b5e664be-9f29-53df-e053-2995a90ad4d6

Reported adverse events (FAERS/openFDA)#

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