FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
GRUPO PIRRETEAM SA DE CV | KUII PRODUCTOS DE LIMPIEZA SA DE CV
Effective date
2020-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:26

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL, CHLORHEXIDINE GLUCONATE
Label structure10 sections

Indications and uses

Uses * Healthcare personnel Handwash. Significant reduce the amount of bacterias on the hands and forearms.

Dosage and administration

Directions: Place enough product in your palm to throughly cover your hands. Rubs hands together briskly until dry Children under 6 years of age should be supervised when using this product

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

Uses

* Healthcare personnel Handwash. Significant reduce the amount of bacterias on the hands and forearms.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

  • Isopropyl Alcohol 60%...................................Antiseptic
  • Chlorhexidine gluconate 0.5%..........................Antiseptic

Warnings

WARNINGS SECTION

  • For external use only
  • When using this product avoid contact with eyes. In case of contact, flush with water for several minutes.
  • Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
  • Stop use and ask Doctor: if skin irritation develops when using this product
  • Flammable: Keep away from heat and flame. Highly flammable liquid and vapor/

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

* Irritation develops while using this product

Keep out of reach of children

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

Directions: Place enough product in your palm to throughly cover your hands.

  • Rubs hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product

Inactive Ingredients

INACTIVE INGREDIENT SECTION

sodium lauryl ether sulfate, cocamide DEA, EDTA disodium salt, ethylene glycol polymer, propylene glycol dicaprate, water

Questions?

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS: Phone: (786) 599-2764. 24 hours a day, 7 days a week

Uses

OTC - PURPOSE SECTION

Uses

* Healthcare personnel Handwash. Significant reduce the amount of bacterias on the hands and forearms.

Hand Soap

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78797-011-012022-01-28C16284748780-1d6a99b39-5ff7-a426-e053-dadaa90af4c2Hand Soap Chlorexidine Gluconate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78797-011-01Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78797-011HAND SANITIZER (ANTISEPTIC) LIQUID [GRUPO PIRRETEAM SA DE CV]1Legacy NDC, 1 package rows20200901_ae2d9f8d-4575-3d47-e053-2995a90ad1e1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78797-01178797-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE SODIUMMP1J8420LUIACT
POLIDOCANOL0AWH8BFG9AIACT
PROPYLENE GLYCOL DICAPRATEU783H9JHWYIACT
COCO DIETHANOLAMIDE92005F972DIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB

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
ae2db9dc-6b37-0f63-e053-2a95a90a012bae2d9f8d-4575-3d47-e053-2995a90ad1e12020-08-31WarningsExact identifier
spl id: ae2db9dc-6b37-0f63-e053-2a95a90a012b
spl set id: ae2d9f8d-4575-3d47-e053-2995a90ad1e1

Reported adverse events (FAERS/openFDA)#

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