5 Percent Benzoyl Peroxide Cleanser Gel
FDA Label NDC 81136-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brand Evangelists For Beauty Limited for the product 5 Percent Benzoyl Peroxide Cleanser (NDC 81136-023). 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 drug facts, active ingredients, purpose, uses, warnings, do not use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzoyl Peroxide 5%
Purpose
Acne Medication
Uses
• for the treatment of acne.
Warnings
For external use only.
Do Not Use If
• you have very sensitive skin• 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.
If Pregnant Or Breastfeeding
ask a health professional before use.
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 stated below.• wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 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 a broad spectrum sunscreen after using this product • if irritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive Ingredients
Aqua (Water), Glycerin, Sodium Laurylglucosides Hydroxypropylsulfonate, Decyl Glucoside, Stearic Acid, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6, Sodium Chloride, Ethylhexylglycerin, SodiumHydroxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate, t-Butyl Alcohol.
Questions Or Comments?
Call toll free (833) 981-2335
* Please review the disclaimer below.
