FDA.reportPublic FDA data

Professional Solutions ® - Antimicrobial Hand Lotion

Manufacturer
Cosmetic Solutions LLC
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:47

Label at a glance#

ProductProfessional Solutions - Antimicrobial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

To decrease bacteria on the skin.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping - for children under 6, use only under adult supervision - not recommended for infants.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

USES

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin.

WARNINGS

WARNINGS SECTION

  • For external use only: Hands only.

OTC - WHEN USING SECTION

  • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid contact with broken skin.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if irritation or redness develops - condition persists for more than 72 hours.

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 thoroughly with product and allow to dry without wiping - for children under 6, use only under adult supervision - not recommended for infants.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Cetyl Alcohol, Behentrimonium Methosulfate, Carthamus Tinctorius Seed Oil, Dimethicone, Propanediol, Butylene Glycol, Calendula Officinalis Flower Extract, Citric Acid, Disodium Phosphate, Equisetum Arvense Extract, Ethylhexylglycerin, Fragrance, Geranium Maculatum Extract, Glycerin, Honey, Lactococcus Ferment Extract, Moringa Oleifera Seed Extract, Panax Ginseng Root Extract, Phenoxyethanol, Salvia Officinalis Leaf Extract, Sambucus Nigra Flower Extract, Sodium Hydroxide.

SPL UNCLASSIFIED SECTION

Manufactured By: Professional Solutions
Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional
Solutions®
PURE SCIENCE. BETTER SKIN

antimicrobial
hand lotion

protect + moisturize

2 fl. oz. (60mL)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-2100-02022-01-28C16284748780-1d6a99b39-5da0-a426-e053-dadaa90af4c2Professional Solutions ® - Antimicrobial Hand Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-2100-0Professional Solutions - Antimicrobial Hand60 mL in 1 BOTTLELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-2100PROFESSIONAL SOLUTIONS - ANTIMICROBIAL HAND (BENZALKONIUM CHLORIDE) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20200717_e3acd070-8aab-437c-b41d-3d5ca4888dd7.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-210066163-2100-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
Water059QF0KO0RIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Cetyl Alcohol936JST6JCNIACT
Behentrimonium Methosulfate5SHP745C61IACT
Safflower Oil65UEH262ISIACT
Dimethicone92RU3N3Y1OIACT
Propanediol5965N8W85TIACT
Butylene Glycol3XUS85K0RAIACT
Calendula Officinalis FlowerP0M7O4Y7YDIACT
Citric Acid Monohydrate2968PHW8QPIACT
Sodium Phosphate, Dibasic, Anhydrous22ADO53M6FIACT
Equisetum Arvense Branch1L0VKZ185EIACT
Ethylhexylglycerin147D247K3PIACT
Geranium Maculatum Root93IXI5B6OJIACT
GlycerinPDC6A3C0OXIACT
HoneyY9H1V576FHIACT
Asian GinsengCUQ3A77YXIIACT
PhenoxyethanolHIE492ZZ3TIACT
Sambucus Nigra Flower07V4DX094TIACT
Sodium Hydroxide55X04QC32IIACT

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
04afb7af-cc96-4ad1-9587-6fe038c07f20e3acd070-8aab-437c-b41d-3d5ca4888dd72020-07-16WarningsExact identifier
spl id: 04afb7af-cc96-4ad1-9587-6fe038c07f20
spl set id: e3acd070-8aab-437c-b41d-3d5ca4888dd7

Reported adverse events (FAERS/openFDA)#

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