FDA.reportPublic FDA data

Brisas-Paveemol 220 mL Alcohol Gel

Manufacturer
Brisas del Caribe Corp. | Paveemol Company Limited
Effective date
2021-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:55

Label at a glance#

ProductFarewell Collection
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 1 800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice powder, aminomethyl propanol, carbomer interpolymer type A, glycerin, maltodextrin, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

220 mL NDC:12961-111-12220 mL NDC:12961-111-12

220 mL NDC:12961-111-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12961-111-112023-01-30C16284748780-1f386c64a-2730-0266-e053-dadaa90a7c1aBrisas-Paveemol 220 mL Alcohol Gel
12961-111-122023-01-30C16284748780-1f386c64a-2730-0266-e053-dadaa90a7c1aBrisas-Paveemol 220 mL Alcohol Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12961-111-11Farewell Collection30 mL in 1 BOTTLEGEL301
12961-111-12Farewell Collection220 mL in 1 BOTTLEGEL2201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12961-111FAREWELL COLLECTION (HAND SANITIZER GEL) GEL [BRISAS DEL CARIBE CORP. ]1Legacy NDC, 2 package rows20210621_c5359447-62f0-0eca-e053-2a95a90a0ecc.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12961-11112961-111-12, 12961-111-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT

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
c5359447-62f1-0eca-e053-2a95a90a0eccc5359447-62f0-0eca-e053-2a95a90a0ecc2021-06-20WarningsExact identifier
spl id: c5359447-62f1-0eca-e053-2a95a90a0ecc
spl set id: c5359447-62f0-0eca-e053-2a95a90a0ecc

Reported adverse events (FAERS/openFDA)#

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