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Benzoyl peroxide - Medication Information

Product NDC Code 77924-002
Drug Name

Benzoyl peroxide

Type Generic
Active Ingredients
Benzoyl peroxide 25 mg/1000mg
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 308689
Application Number M006
Labeler Name Malezia LLC
Packages
Package NDC Code Description
77924-002-02 50000 mg in 1 tube (77924-002-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
50 mL NDC: 77924-002-01 active ingredient

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.
50 mL NDC: 77924-002-01 dosage and adminstration

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
50 mL NDC: 77924-002-01 inactive ingredients

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.
50 mL NDC: 77924-002-01 indications and usage

Purpose

Information about the drug product’s indications for use.
50 mL NDC: 77924-002-01 purpose

Spl product data elements

Usually a list of ingredients in a drug product.
Benzoyl Peroxide Benzoyl Peroxide GLYCERIN SODIUM HYDROXIDE WATER CARBOMER 980 BENZOYL PEROXIDE BENZOYL PEROXIDE PHYTATE SODIUM PROPANEDIOL

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.
50 mL NDC: 77924-002-01 Front of Malezia BP Label Back of BP Label 50 mL NDC: 77924-002-01 dosage and adminstration 50 mL NDC: 77924-002-01 Warning section 50 mL NDC: 77924-002-01 inactive ingredients 50 mL NDC: 77924-002-01 active ingredient 50 mL NDC: 77924-002-01 purpose 50 mL NDC: 77924-002-01 indications and usage 50 mL NDC: 77924-002-01 children warning

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.
50 mL NDC: 77924-002-01 children warning

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.
50 mL NDC: 77924-002-01 Warning section

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