Benzoyl Peroxide BENZOYL PEROXIDE BUREL PHARMACEUTICALS, LLC FDA Approved Use For the treatment of acne

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient benzoyl peroxide USP 5% or 10%
Inactive Ingredients
Inactive Ingredients Carbomer interpolymer type A NF cetyl alcohol NF 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.
Strengths
5 % 10 %
Treats Conditions
Use For The Treatment Of Acne
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOTTLE
UPC
0335573454081 0335573454913
UNII
W9WZN9A0GM
Packaging

PRINCIPAL DISPLAY PANEL - 5% 5oz (148 g) Bottle Label NDC 35573-453-91 BENZOYL PEROXIDE TOPICAL WASH 5% FOR TOPICAL USE ONLY Net Weight 5 oz (148 g) burelpharma lelys; PRINCIPAL DISPLAY PANEL - 5% 8oz (237 g) Bottle Label NDC 35573-453-08 BENZOYL PEROXIDE TOPICAL WASH 5% FOR TOPICAL USE ONLY Net Weight 8 oz (237 g) burelpharma lelys; PRINCIPAL DISPLAY PANEL - 10% 5oz (148 g) Bottle Label NDC 35573-454-91 BENZOYL PEROXIDE TOPICAL WASH 10% FOR TOPICAL USE ONLY Net Weight 5 oz (148 g) burelpharma lelys1; PRINICIPAL DISPLAY PANEL - 10% 8oz (237 g) Bottle Label NDC 35573-454-08 BENZOYL PEROXIDE TOPICAL WASH 10% FOR TOPICAL USE ONLY Net Weight 8 oz (237 g) burelpharma lelys3

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 5% 5oz (148 g) Bottle Label NDC 35573-453-91 BENZOYL PEROXIDE TOPICAL WASH 5% FOR TOPICAL USE ONLY Net Weight 5 oz (148 g) burelpharma lelys
  • PRINCIPAL DISPLAY PANEL - 5% 8oz (237 g) Bottle Label NDC 35573-453-08 BENZOYL PEROXIDE TOPICAL WASH 5% FOR TOPICAL USE ONLY Net Weight 8 oz (237 g) burelpharma lelys
  • PRINCIPAL DISPLAY PANEL - 10% 5oz (148 g) Bottle Label NDC 35573-454-91 BENZOYL PEROXIDE TOPICAL WASH 10% FOR TOPICAL USE ONLY Net Weight 5 oz (148 g) burelpharma lelys1
  • PRINICIPAL DISPLAY PANEL - 10% 8oz (237 g) Bottle Label NDC 35573-454-08 BENZOYL PEROXIDE TOPICAL WASH 10% FOR TOPICAL USE ONLY Net Weight 8 oz (237 g) burelpharma lelys3

Overview

Use For the treatment of acne

Indications & Usage

Use For the treatment of acne

Dosage & Administration

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.

Warnings & Precautions
Warnings: For external use only. Avoid contact with eyes, eyelids, lips and mucous membranes. Do not use if you have very sensitive skin are sensitive to benzoyl peroxide 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. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Acne medication

Do Not Use

Do not use if you have very sensitive skin are sensitive to benzoyl peroxide

When Using

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.

Keep Out of Reach of Children

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information Store at controlled room temperature, 15° - 30°C (59° - 86°F)


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