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| Product NDC Code | 35573-453 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Benzoyl peroxide |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 142034, 308696 |
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| Application Number | M006 | ||||||
| Labeler Name | Burel Pharmaceuticals, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient benzoyl peroxide USP, 5% or 10%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For the treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne medication
Spl product data elements
Usually a list of ingredients in a drug product.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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Questions? Call 1-866-525-0688 Manufactured for: Burel Pharmaceuticals, LLC Mason, OH 45040 USA Rev. 04/24
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have very sensitive skin are sensitive to benzoyl peroxide
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at controlled room temperature, 15° - 30°C (59° - 86°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API