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| Product NDC Code | 71399-9236 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Medpura benzoyl peroxide |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 142034, 308696 |
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| Application Number | part333D | ||||||
| Labeler Name | Akron Pharma Inc. | ||||||
| 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 5% Benzoyl peroxide 10% Purpose Acne treatment
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 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. wet area to be cleansed apply acne wash and gently massage area for 1-2 minutes 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. 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 citric acid, edetate disodium, germall 115, glycerin, phophomer x polymer, purified water, sodium olefin sulfonate, sodium hydroxide
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.MEDPURA Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide DOCUSATE SODIUM ALCOHOL METHYL SALICYLATE 2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE water SODIUM HYDROXIDE MEDPURA Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide DOCUSATE SODIUM ALCOHOL METHYL SALICYLATE 2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE water SODIUM HYDROXIDE
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.image description image description
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
Manufactured for: Akron Pharma, Inc. Fairfield, NJ-07004 www.akronpharma.com
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 this medication if you have very sensitive skin or if you 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. (1-800-222-1222)
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? call toll-free 1-877-225-6999
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, eyelids and mucous membranes. 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.
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 Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide. When using this product avoid unnecessary sun exposure and use a sunscreen. avoid contact with eyes, lips, and mouth, eyelids and mucous membranes. 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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