ROYCEDERM ANTIBACTERIAL BODY WASH- benzalkonium chloride 0.13% gel

RoyceDerm Antibacterial Body Wash by

Drug Labeling and Warnings

RoyceDerm Antibacterial Body Wash by is a Otc medication manufactured, distributed, or labeled by RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

PURPOSE

Antiseptic

DOSAGE & ADMINISTRATION

For skin cleansing to decrease bacterial presence

WARNINGS

For external use only

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

If irritaion occurs or redness develops.

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

INDICATIONS & USAGE

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

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

QUESTIONS

Email: service@roycederm.com

Tel: +1(307)461-0958

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM ANTIBACTERIAL BODY WASH 
benzalkonium chloride 0.13% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.65 g  in 500 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARAMEL (UNII: T9D99G2B1R)
CITRIC ACID (UNII: 2968PHW8QP)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
SODIUM HYALURONATE CROSSPOLYMER-1 (UNII: 4D4QKG9VN2)
COCAMIDE METHYL MEA (UNII: 79G1T427CF)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
NIACINAMIDE (UNII: 25X51I8RD4)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
MENTHOL (UNII: L7T10EIP3A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
ALLANTOIN (UNII: 344S277G0Z)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
COCO-GLUCOSIDE (UNII: ICS790225B)
COCONUT ACID (UNII: 40U37V505D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYALURONIC ACID (UNII: S270N0TRQY)
OATMEAL (UNII: 8PI54V663Y)
GLYCERETH-26 (UNII: NNE56F2N14)
HONEY (UNII: Y9H1V576FH)
MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-016-01	500 g in 1 CARTON; Type 0: Not a Combination Product	02/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	02/26/2026

Labeler - RoyceDerm LLC (130329531)