FDA.reportPublic FDA data

Flower Pelle Bubble Antibacterial Hand Wash

Manufacturer
F&I
Effective date
2020-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:42

Label at a glance#

ProductFlower Pelle Bubble Antibacterial Hand Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Pump into hands, wet as needed. Lather vigorously for at least 10 seconds. Wash hands, rinse thoroughly and dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • For hand sanitizer to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes. In case of eye contact, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Pump into hands, wet as needed.
Lather vigorously for at least 10 seconds.
Wash hands, rinse thoroughly and dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Glycerin, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Cocamide MIPA, Sodium Chloride, Fragrance, Citric acid, Butylene Glycol, Hexylene glycol, Isopropanolamine, 1,2-Hexanediol, Portulaca Oleracea Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2470932benzalkonium chloride 0.05 % Medicated Liquid SoapPSN1
2470932benzalkonium chloride 0.5 MG/ML Medicated Liquid SoapSCD1
2470932benzalkonium chloride 0.05 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81328-001-022022-01-28C16284748780-1d6a99b39-80c0-a426-e053-dadaa90af4c281328-001_Flower Pelle Bubble Antibacterial Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81328-001-01Flower Pelle Bubble Antibacterial Hand Wash250 mL in 1 BOTTLE, PUMPLIQUID2501
81328-001-02Flower Pelle Bubble Antibacterial Hand Wash1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81328-001FLOWER PELLE BUBBLE ANTIBACTERIAL HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [F&I]1Legacy NDC, 2 package rows20201223_8b8aadf3-2be7-4c3e-97a6-3fc660fe0d75.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81328-00181328-001-01, 81328-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
ISOPROPANOLAMINEUE40BY1BZWIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PURSLANEM6S840WXG5IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
b70aa944-47da-475b-e053-2a95a90ae8048b8aadf3-2be7-4c3e-97a6-3fc660fe0d752020-12-22WarningsExact identifier
spl id: b70aa944-47da-475b-e053-2a95a90ae804
spl set id: 8b8aadf3-2be7-4c3e-97a6-3fc660fe0d75

Reported adverse events (FAERS/openFDA)#

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