FDA.reportPublic FDA data

Brisas-Paveemol Shower Cream nut Label

Manufacturer
Brisas del Caribe Corp. | Paveemol Company Limited
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:29

Label at a glance#

ProductFarewell Collection
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Apply on skin thoroughly, wash, and rinse. Suitable to daily use. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15 and 30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.05 %.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

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

  • Apply on skin thoroughly, wash, and rinse. Suitable to daily use.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15 and 30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates copolymer, aloe barbadensis leaf extract, chlorphenesin, cocamidopropyl betaine, disodium EDTA, glycerin, glycol distearate, maltodextrin, phenoxyethanol, polyquaternium-7, propylene glycol, purified water USP, shea butter, sodium benzoate, sodium coco-sulfate, sodium laureth sulfate, triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL NDC : 12961-115-11250 mL NDC : 12961-115-11250 mL NDC : 12961-115-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2470932benzalkonium chloride 0.05 % Medicated Liquid SoapPSN3
2470932benzalkonium chloride 0.5 MG/ML Medicated Liquid SoapSCD3
2470932benzalkonium chloride 0.05 % Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12961-115-112024-01-30C16284748780-11030e365-3112-111a-e063-dadaa90a10e2Brisas-Paveemol Shower Cream nut Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12961-115-11Farewell Collection250 mL in 1 BOTTLE, DISPENSINGCREAM2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12961-115FAREWELL COLLECTION (ANTISEPTIC SHOWER CREAM) CREAM [BRISAS DEL CARIBE CORP. ]3Legacy NDC, 1 package rows20221217_c55da493-5c54-e5cc-e053-2a95a90a2483.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12961-11512961-115-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURYL SULFATE368GB5141JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
TROLAMINE9O3K93S3TKIACT
SODIUM COCO-SULFATE3599J29ANHIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCOL DISTEARATE13W7MDN21WIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM BENZOATEOJ245FE5EUIACT
SHEA BUTTERK49155WL9YIACT
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
efd6d66b-438a-a968-e053-2995a90a2470c55da493-5c54-e5cc-e053-2a95a90a24832022-12-14WarningsExact identifier
spl id: efd6d66b-438a-a968-e053-2995a90a2470
spl set id: c55da493-5c54-e5cc-e053-2a95a90a2483

Reported adverse events (FAERS/openFDA)#

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