说明与适用边界
此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。
spl product data elements
Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerin GLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol water sodium coco-sulfate sodium lauroamphoacetate xanthan gum viscous Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerin GLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol water sodium coco-sulfate sodium lauroamphoacetate xanthan gum viscous
spl unclassified section
DRUG FACTS
Questions? Call 1-866-525-0688 Manufactured for: Burel Pharmaceuticals, LLC Mason, OH 45040 USA Rev. 04/24
活性成分 / Active ingredient
Active Ingredient benzoyl peroxide USP, 5% or 10%
用途 / Purpose
Purpose Acne medication
适应证 / Indications and usage
Use For the treatment of acne
警告 / Warnings
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.
禁用事项 / Do not use
Do not use if you have very sensitive skin are sensitive to benzoyl peroxide
使用中 / 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.
儿童安全 / 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.
用法用量原文 / Dosage and 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.
储存 / Storage and handling
Other information Store at controlled room temperature, 15° - 30°C (59° - 86°F)
辅料 / 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.
package label principal display panel
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
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20240424
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

