FDA.reportPublic FDA data

RoyceDerm Antibacterial Body Wash - RoyceDerm LLC

Manufacturer
RoyceDerm LLC
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:42

Label at a glance#

ProductRoyceDerm Antibacterial Body Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Antiseptic

DOSAGE & ADMINISTRATION SECTION

For skin cleansing to decrease bacterial presence

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

If irritaion occurs or redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medicaladvice immediately or contact a Poison Control Center right away. (1-800-222-1222)

INDICATIONS & USAGE SECTION

Dispense onto palm or washcloth. Gently massage and lather over entire body. Leave onskinfor 1-2 minutes, then rinse thoroughly.

OTHER SAFETY INFORMATION

Store at room temperature

INACTIVE INGREDIENT SECTION

Water, Sodium C14-16 Olefin Sulfonate, Cocamido-propyl Betaine, Glycerin, Coco-Glucoside, PEG-40 Hydrogenated Castor Oil, Acrylates Copolymer,Cocamide Methyl MEA, Melaleuca Alternifolia (TeaTree) Leaf Oil, Aloe Barbadensis Leaf Water, Sodium Chloride, Phenoxyethanol, Eucalyptus Globulus LeafOil, Sodium Cocoyl Isethionate, Mentholum, Decyl Glucoside, Chlorphenesin, Maltooligosyl Glucoside,Allantoin, Niacinamide, Sodium Hydroxide, Hydrogenated Starch Hydrolysate, Coconut Acid, Disodium EDTA,Butylene Glycol, Citric Acid, Phospholipids,Hydroxyphenyl Propamidobenzoic Acid, Caramel,Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate, Avena Sativa (Oat) Kernel Flour, Cocos Nucifera(Coconut) Oil, Olea Europaea (Olive) Fruit Oil,Hydroxyethyl Urea, Glycereth-26, Honey Extract,Hyaluronic Acid, Sodium Hyaluronate Crosspolymer

OTC - QUESTIONS SECTION

Email: service@roycederm.com

Tel: +1(307)461-0958

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850068161621GTIN-13: 0850068161621
EAN-13: 0850068161621
GTIN-12: 850068161621
UPC-A: 850068161621
GTIN storage (14 digits): 00850068161621		package.jpg
QR code linkQR Codeqrco.de/bgA6zJpackage.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-016-01RoyceDerm Antibacterial Body Wash500 g in 1 CARTONGEL5001

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-01685424-016-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARAMELT9D99G2B1RIACT
CITRIC ACID2968PHW8QPIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
SODIUM HYALURONATE CROSSPOLYMER-14D4QKG9VN2IACT
COCAMIDE METHYL MEA79G1T427CFIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM COCOYL ISETHIONATE518XTE8493IACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
NIACINAMIDE25X51I8RD4IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
CALCIUM DISODIUM EDTA8U5D034955IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
MENTHOLL7T10EIP3AIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
ALLANTOIN344S277G0ZIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
COCO-GLUCOSIDEICS790225BIACT
COCONUT ACID40U37V505DIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYALURONIC ACIDS270N0TRQYIACT
OATMEAL8PI54V663YIACT
GLYCERETH-26NNE56F2N14IACT
HONEYY9H1V576FHIACT
MALTOOLIGOSYL GLUCOSIDEN91S91EFOGIACT

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
RoyceDerm Antibacterial Body WashBENZALKONIUM CHLORIDE 0.13%RoyceDerm LLC4a0c66b1-5a6f-b9b9-e063-6294a90a3d772026-02-04WarningsExact identifier
ndc (package): 85424-016-01
ndc (product): 85424-016
ndc11 (package): 85424001601
spl id: 4a0c66b1-5a70-b9b9-e063-6294a90a3d77
spl set id: 4a0c66b1-5a6f-b9b9-e063-6294a90a3d77

Reported adverse events (FAERS/openFDA)#

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