Label: BENZOYL PEROXIDE liquid
- NDC Code(s): 35573-453-08, 35573-453-91, 35573-454-08, 35573-454-91
- Packager: Burel Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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Warnings:
For external use only.
- Avoid contact with eyes, eyelids, lips and mucous membranes.
When using this product
- Avoid unnecessary sun exposure and use a sunscreen.
- Avoid contact with eyes, lips, and mouth.
- Avoid contact with hair or 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.
- 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.
- Stop use and ask a doctor if irritation becomes severe.
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Directions
SHAKE WELL.
- Clean the skin thoroughly before applying this product.
- 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.
- One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
- Follow directions in the sunscreen labeling.
- If irritation or sensitivity develops stop use of both products and ask a doctor.
- Other information
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Inactive Ingredients
Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5% 5oz (148 g) Bottle Label
- PRINCIPAL DISPLAY PANEL - 5% 8oz (237 g) Bottle Label
- PRINCIPAL DISPLAY PANEL - 10% 5oz (148 g) Bottle Label
- PRINICIPAL DISPLAY PANEL - 10% 8oz (237 g) Bottle Label
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35573-453 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength cetyl alcohol (UNII: 936JST6JCN) DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY) edetate disodium (UNII: 7FLD91C86K) glycerin (UNII: PDC6A3C0OX) laureth-12 (UNII: OAH19558U1) magnesium aluminum silicate (UNII: 6M3P64V0NC) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium coco-sulfate (UNII: 3599J29ANH) sodium lauroamphoacetate (UNII: SLK428451L) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color white (viscous) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35573-453-91 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2022 2 NDC:35573-453-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 04/15/2022 BENZOYL PEROXIDE
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35573-454 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength cetyl alcohol (UNII: 936JST6JCN) DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY) edetate disodium (UNII: 7FLD91C86K) glycerin (UNII: PDC6A3C0OX) laureth-12 (UNII: OAH19558U1) magnesium aluminum silicate (UNII: 6M3P64V0NC) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium coco-sulfate (UNII: 3599J29ANH) sodium lauroamphoacetate (UNII: SLK428451L) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color white (viscous) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35573-454-91 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2022 2 NDC:35573-454-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 04/15/2022 Labeler - Burel Pharmaceuticals, LLC (609436204) Establishment Name Address ID/FEI Business Operations Groupe PARIMA Inc. 252437850 label(35573-453, 35573-454) , manufacture(35573-453, 35573-454) , pack(35573-453, 35573-454)
