FDA.reportPublic FDA data

Prime Source ULTRA Energy Plum Antibacterial Dye Free Foam Hand So ap

Manufacturer
BUNZL Distribution
Effective date
2020-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:00:03

Label at a glance#

ProductPrime Source ULTRA Energy Plum Antibacterial Dye Free Foam Hand So ap
Active ingredientBenzalkonium Chloride
Label structure7 sections

Indications and uses

• Handwash to help decrease bacteria on the skin • Recommended for repeated use

Dosage and administration

• Wet hands • Apply a small amount of product and work into a lather • Rinse well and dry hands completely

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.5%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

• Handwash to help decrease bacteria on the skin

• Recommended for repeated use

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 contact, rinse eyes thoroughly 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hands

• Apply a small amount of product and work into a lather

• Rinse well and dry hands completely

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Propanediol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Fragrance (Parfum), Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66294-43166294-431-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Water059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
GlycerinPDC6A3C0OXIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
PEG-80 Sorbitan Laurate239B50Y732IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
Ethylhexylglycerin147D247K3PIACT
Lauramine Oxide4F6FC4MI8WIACT
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)PI1STR9QYHIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
64648bfe-4182-438a-a742-18275e0757141815ca2d-5c6b-48e0-96a5-8a6e291e4fb22020-12-22WarningsExact identifier
spl id: 64648bfe-4182-438a-a742-18275e075714
spl set id: 1815ca2d-5c6b-48e0-96a5-8a6e291e4fb2

Reported adverse events (FAERS/openFDA)#

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