Otc - Active Ingredient
Benzalkonium Chloride 0.13%
Roycederm Antibacterial Body Wash Gel
FDA Label NDC 85424-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Antibacterial Body Wash (NDC 85424-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Dosage & Administration
For skin cleansing to decrease bacterial presence
Warnings
For external use only
Otc - When Using
do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Ask Doctor
If irritaion occurs or redness develops.
Otc - Keep Out Of Reach Of Children
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
Otc - Questions
Email: [email protected]
Tel: +1(307)461-0958
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