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| Product NDC Code | 0299-4611 | ||||
|---|---|---|---|---|---|
| Drug Name | Differin 10% bpo acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| Application Number | M006 | ||||
| Labeler Name | Galderma Laboratories, L.P. | ||||
| 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 Ingredients Benzoyl Peroxide 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 • 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 ■ clean the skin thoroughly before applying this product ■ cover the entire affected area with a thin layer one to three times daily ■ 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. 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 Acrylates Copolymer, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Disodium EDTA, Glycerin, Poloxamer 182, Propylene Glycol, Silica, Sodium Hydroxide, Water
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.Uses For the treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.Differin 10% BPO Acne Treatment benzoyl peroxide Benzoyl Peroxide Benzoyl Peroxide Butyl Acrylate/Methyl Methacrylate/Methacrylic Acid Copolymer (18000 Mw) Carbomer Homopolymer, Unspecified Type Docusate Sodium Edetate Disodium Anhydrous Glycerin Poloxamer 182 Propylene Glycol Silicon Dioxide Sodium Hydroxide Water P57672-0 carton image
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.Principle Display Panel - 1 OZ (28 g) carton NEW DIFFERIN ® Acne Spot Treatment 10% BENZOYL PEROXIDE Acne Treatment MAXIMUM STRENGTH Reduces Acne Size & Redness VISIBLE RESULTS AFTER 1 DAY NET WT 1 OZ (28 g) P57672-0
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-735-4137
Distributed by: Galderma Laboratories, L.P. Dallas, TX 75201 USA All trademarks are the property of their respective owners Made in Canada www.differin.com
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. 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.
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