FDA.reportPublic FDA data

Hand Sanitizer Anti bacterial Gel

Manufacturer
GRUPO PIRRETEAM SA DE CV | KUII PRODUCTOS DE LIMPIEZA SA DE CV
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:54

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Uses * Helps eliminated bacterias on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

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

* Helps eliminated bacterias on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

  • Ethyl Alcohol 70%...................................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

isopropyl alcohol, water, carbomer, benzalkonium chloride

Questions?

OTC - QUESTIONS SECTION

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

Uses

OTC - PURPOSE SECTION

Uses

* Helps eliminated bacteria on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Hand Sanitizer Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78797-004-012022-01-28C16284748780-1d6a99b39-f4d3-a426-e053-dadaa90af4c2Hand Sanitizer Anti bacterial Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78797-004-01Hand Sanitizer18927 mL in 1 BOTTLE, PLASTICGEL189271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78797-004HAND SANITIZER (ALCOHOL) GEL [GRUPO PIRRETEAM SA DE CV]1Legacy NDC, 1 package rows20200610_a7aa3f59-8fc5-237a-e053-2a95a90aecf2.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
78797-00478797-004-01

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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
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
a7aa3f64-4fe6-7b08-e053-2995a90a35a7a7aa3f59-8fc5-237a-e053-2a95a90aecf22020-06-09WarningsExact identifier
spl id: a7aa3f64-4fe6-7b08-e053-2995a90a35a7
spl set id: a7aa3f59-8fc5-237a-e053-2a95a90aecf2

Reported adverse events (FAERS/openFDA)#

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