FDA.reportPublic FDA data

Serene Clean and Pure Antibacterial Hand

Manufacturer
Serene Clean & Pure LLC | Morgan Gallacher Inc.
Effective date
2020-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:11

Label at a glance#

ProductSerene Clean and Pure Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Pump into wet hands and work into a lather for at least 15 seconds Rinse thoroughly and dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

For handwashing to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops and condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pump into wet hands and work into a lather for at least 15 seconds
  • Rinse thoroughly and dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, EDTA, Glycerin, Sodium Dodecylbenzenesulfonate, Coco-betaine, Sodium Laureth Sulfate, Phenoxyethanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Serene Clean & Pure

Kills 99.99% of Germs & Bacteria

Benzalkonium Chloride

Antibacterial Hand Soap

16 fl oz

www.serenepure.com

ABOUT

Serene Clean & Pure is a family owned company that believes in honest and helpful products.

Serene Clean & Pure hand soap is an antibacterial hand soap that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life

Distributed by:

Serene Clean & Pure

555 Anton Blvd. Suite 105

Costa Mesa, CA 92626

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78643-200-012022-01-28C16284748780-1d6a99b39-ab28-a426-e053-dadaa90af4c2Serene Clean & Pure Antibacterial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78643-200-01Serene Clean and Pure Antibacterial Hand473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78643-200SERENE CLEAN AND PURE ANTIBACTERIAL HAND (BENZAKONIUM CHLORIDE) LIQUID [SERENE CLEAN & PURE LLC]1Legacy NDC, 1 package rows20200714_aa0f9ffe-4bad-6799-e053-2995a90abf14.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78643-20078643-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETIC ACID9G34HU7RV0IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
COCO-BETAINE03DH2IZ3FYIACT
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
aa0f9ffe-4bae-6799-e053-2995a90abf14aa0f9ffe-4bad-6799-e053-2995a90abf142020-07-09WarningsExact identifier
spl id: aa0f9ffe-4bae-6799-e053-2995a90abf14
spl set id: aa0f9ffe-4bad-6799-e053-2995a90abf14

Reported adverse events (FAERS/openFDA)#

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