FDA.reportPublic FDA data

PrimeGel Antiseptic Hand Sanitizer Gel 80 Ethyl Alcohol

Manufacturer
FIGUEIRA E FELICIANO INDUSTRIA DE COSMETICOS LTDA
Effective date
2021-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:39

Label at a glance#

ProductPrimeGel Antiseptic Hand Sanitizer Gel 80 Ethyl Alcohol
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation and redness develop.
  • Condition persists for more than 72 hours.

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

Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

  • Do not store above 104°F (40°C). 
  • Keep the container tightly closed in a cool, well-ventilated place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, glycerin, hydrogen peroxide, triethanolamine, water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81717-001-012022-07-29C16284748780-1e4f33bdf-9d86-d8a0-e053-dadaa90a6e4ePrimeGel Antiseptic Hand Sanitizer Gel 80% Ethyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81717-001-01PrimeGel Antiseptic Hand Sanitizer Gel 80 Ethyl Alcohol500 mL in 1 BOTTLE, PLASTICGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81717-001PRIMEGEL ANTISEPTIC HAND SANITIZER GEL 80 ETHYL ALCOHOL (ALCOHOL) GEL [FIGUEIRA E FELICIANO INDUSTRIA DE COSMETICOS LTDA]1Legacy NDC, 1 package rows20210601_c29eccf9-dd43-20a1-e053-2995a90a3a0d.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
81717-00181717-001-01

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
c29ed810-5ab2-036b-e053-2995a90a7c0ec29eccf9-dd43-20a1-e053-2995a90a3a0d2021-05-18WarningsExact identifier
spl id: c29ed810-5ab2-036b-e053-2995a90a7c0e
spl set id: c29eccf9-dd43-20a1-e053-2995a90a3a0d

Reported adverse events (FAERS/openFDA)#

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