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| Product NDC Code | 84339-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Benzoyl peroxide |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | CUTANEOUS | ||||
| Dosage Form | GEL | ||||
| Application Number | M006 | ||||
| Labeler Name | Enrich Enterprises Xiamen Limited | ||||
| 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.Benzoyl Peroxide 2.5%
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.- Clean the skin gently before applying this product. - Cover the affected area with a fingertip unit of product once or twice daily. - If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Water, Propanediol, Glycerin, Carbomer, Sodium Phytate, 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.Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.Benzoyl Peroxide Benzoyl Peroxide CARBOMER 980 SODIUM HYDROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE PROPANEDIOL PHYTATE SODIUM WATER GLYCERIN
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.84339-001-01
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 - 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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.- If swallowed get medical help or call poison control center immediately.
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 an SPF. -Avoid contact with the eyes, lips, mouth and hair. - Skin irritation, redness, burning, itching or peeling may occur. - Only use one topical acne medication at a time as skin irritation and dryness is more likely to occur. - Keep out of reach of children. -If swallowed get medical help or call poison control center immediately.
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.- 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