FDA.reportPublic FDA data

Hand Gel Prolim Instant Hand Sanitizer

Manufacturer
Prolim Quimica Avancada Ltda.
Effective date
2010-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:50

Label at a glance#

ProductHand Gel Prolim Instant Hand Sanitizer
Active ingredientAlcohol
Label structure12 sections

Indications and uses

Recommended for aseptic hand cleansing. This product does not replace the use of soap and water. Recommended for repeated use.

Dosage and administration

Place a small amount of product in your hand. Rub hands together briskly for at least 30 seconds until dry. Children under 6 years of age should use under adult supervision.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Recommended for aseptic hand cleansing. This product does not replace the use of soap and water.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. In case of accidental contact, flush eyes thoroughly with water for 15 minutes.
  • Avoid contact with broken skin or you have allergies to any ingredients.

OTC - STOP USE SECTION

Stop use and consult a doctor if skin irritation occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion drink plenty of water and seek medical help or contact a Poison Controll Center immediately.
  • External use only.

SPL UNCLASSIFIED SECTION

FLAMMABLE: Keep out of heat.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place a small amount of product in your hand.
  • Rub hands together briskly for at least 30 seconds until dry.
  • Children under 6 years of age should use under adult supervision.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol,  Carbomer, DDM Hydantoin, Aminomethyl Propanol, Fragrance.

Questions?

OTC - QUESTIONS SECTION

555-555-5555

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label - bottleimage of label - bottle

HAND GEL PROLIM
INSTANT HAND SANITIZER
Kills 99,99% of most commom germs
2.7 OZ FL (80ml)

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
50414-100-012019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-022019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-032019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-042019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-052019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-062019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-072019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-082019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts
50414-100-092019-10-21C16284748780-1956f9ecf-bf7f-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50414-100-01Hand Gel Prolim Instant Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL601
50414-100-02Hand Gel Prolim Instant Hand Sanitizer80 mL in 1 BOTTLE, PLASTICGEL801
50414-100-03Hand Gel Prolim Instant Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001
50414-100-04Hand Gel Prolim Instant Hand Sanitizer200 mL in 1 BOTTLE, PUMPGEL2001
50414-100-05Hand Gel Prolim Instant Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
50414-100-06Hand Gel Prolim Instant Hand Sanitizer1000 mL in 1 BOTTLE, PUMPGEL10001
50414-100-07Hand Gel Prolim Instant Hand Sanitizer5000 mL in 1 BOTTLE, PLASTICGEL50001
50414-100-08Hand Gel Prolim Instant Hand Sanitizer1 in 1 BOXGEL11
50414-100-08Hand Gel Prolim Instant Hand Sanitizer800 mL in 1 BAGGEL8001
50414-100-09Hand Gel Prolim Instant Hand Sanitizer1 in 1 BOXGEL11
50414-100-09Hand Gel Prolim Instant Hand Sanitizer1200 mL in 1 BAGGEL12001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50414-100HAND GEL PROLIM INSTANT HAND SANITIZER (ALCOHOL) GEL [PROLIM QUIMICA AVANCADA LTDA.]1Legacy NDC, 11 package rows20100310_2c0441c7-96e9-4b2b-b851-527badd7429a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
AlcoholACTIVE MOIETY3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50414-10050414-100-01, 50414-100-02, 50414-100-03, 50414-100-04, 50414-100-05, 50414-100-06, 50414-100-07, 50414-100-08, 50414-100-09

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
ac63737f-53f9-4668-8921-78f25a44f20b2c0441c7-96e9-4b2b-b851-527badd7429a2010-02-15WarningsExact identifier
spl id: ac63737f-53f9-4668-8921-78f25a44f20b
spl set id: 2c0441c7-96e9-4b2b-b851-527badd7429a

Reported adverse events (FAERS/openFDA)#

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