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| Product NDC Code | 0187-0201 | ||||
|---|---|---|---|---|---|
| Drug Name | Benzefoam ultra |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL | ||||
| Application Number | part333D | ||||
| Labeler Name | Bausch Health US, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzoyl Peroxide (9.8%)
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 ▪ clean the skin thoroughly before applying this product ▪ cover the entire affected area with a thin layer one to three times daily ▪ rinse off after 2 minutes ▪ 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 ▪ to be used as a short contact application
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, hydrofluorocarbon 134a, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, steareth-10
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 Treatment
Spl product data elements
Usually a list of ingredients in a drug product.BenzEFoam Ultra benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE BUTYLATED HYDROXYTOLUENE ALKYL (C12-15) BENZOATE CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE DIMETHICONE EDETATE DISODIUM ANHYDROUS GLYCERIN NORFLURANE METHYLPARABEN PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM STEARETH-10 POLYSORBATE 60
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.Package/Label Principal Display Panel - Carton NDC: 0187-0194-10 BenzEFoam Ultra benzoyl peroxide 9.8% Acne Treatment Short Contact Foam For Topical Use Only Do Not Use in Eyes Will not dispense entire contents. Container is overfilled to guarantee dispensing a minimum of 100 grams. Back Applicator Included Ortho Dermatologics Net Wt 3.5 OZ (100 g) carton.jpg
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.Do not use if you ■ have very sensitive skin ■ are sensitive to benzoyl peroxide
When using this product ▪ skin irritation and dryness are 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. ▪ do not puncture or incinerate container. Contents under pressure. ▪ do not expose to temperatures above 120°F (49°C).
Stop use and ask a doctor if ■ irritation becomes severe
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ store at room temperature 15°-25°C (59°-77°F). Protect from freezing. Store upright.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions/comments? Call: 1-800-321-4576
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
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