Active Ingredient
Benzoyl Peroxide 10%
Hermon Benzoyl Peroxide Body Wash Liquid
FDA Label NDC 85398-034
12 label sections · Submitted to the FDA by Beautivity Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Hermon Benzoyl Peroxide Body Wash (NDC 85398-034). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Uses
For the treatment of acne.
Warnings
For external use only.
Do Not Use
if you have very sensitive skin; if you are sensitive to benzoyl peroxide.
When Using This Product
Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid unnecessary sun exposure and use a sunscreen. Avoid contact with the eyes, lips, and mouth. Avoid contact with hair and dyed fabrics, which may be bleached by this product. Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use And Ask A Doctor If
irritation becomes severe.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions below. Wet the affected area. Apply AcneWash and gently massage into damp skin. Allow 1 to 3 minutes before rinsing thoroughly with water. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive Ingredients
Water (Aqua), Glyceryl Stearate, Potassium Myristate, PEG-32, Potassium Stearate, Potassium Palmitate, Potassium Laurate, Glycol Distearate, Cocamide MEA, Cetyl Alcohol, Zinc Oxide, Butylene Glycol, Phenoxyethanol, Hydroxyethylcellulose, Sodium Chloride, Disodium EDTA, Ethylhexylglycerin, Cetrimonium Bromide, Hexylene Glycol, Glycine, Ribonucleic Acid, Cinnamomum Zeylanicum (Cinnamon) Bark Extract, 1,2-Hexanediol, 1,3-Propanediol, Hydroxyacetophenone, Portulaca Oleracea Extract, Capryloyl Glycine.
Questions Or Comments?
Visit www.hermonhealth.com. Tel: +1 (573) 476-4179.
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