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| Product NDC Code | 68071-2307 | ||||
|---|---|---|---|---|---|
| Drug Name | Benzoyl peroxide acne medication |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 308694 | ||||
| Application Number | M014 | ||||
| Labeler Name | NuCare Pharmaceuticals,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% 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 Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, 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.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.Benzoyl Peroxide Acne Medication Benzoyl Peroxide CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM EDETATE DISODIUM LAURETH-4 SODIUM HYDROXIDE TITANIUM DIOXIDE WATER BENZOYL PEROXIDE BENZOYL PEROXIDE
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 - PDP
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
Distributed by: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150
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. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.
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? 1-800-645-2158
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 n keep away from eyes, lips and mouth avoid unnecessary sun exposure and use a sunscreen avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor. using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other information Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° 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 n keep away from eyes, lips and mouth avoid unnecessary sun exposure and use a sunscreen avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor. using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.
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