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Product NDC Code | 55621-017 | ||||
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Drug Name | Modesa acne treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 106315 | ||||
Application Number | M006 | ||||
Labeler Name | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Benzoyl peroxide 10%
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 the skin thoroughly before applying medication •cover the entire affected area with a thin layer one to three times a day •because excessive drying of the skin may occur, start with one applicaiton daily, then gradually increase to two to 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.aluminum hydroxide, bentonite, Inactive ingredients carbomer, glycerin monostearate, isopropyl myristate, methylparaben, peg-12, potassium hydroxide, propylene glycol, propylparaben, 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.for the treatment and prevention of acne pimples Uses
Purpose
Information about the drug product’s indications for use.Purpose Acne medication
Spl product data elements
Usually a list of ingredients in a drug product.Modesa Acne Treatment BENZOYL PEROXIDE ALUMINUM HYDROXIDE BENTONITE CARBOMER 940 DIGLYCERIN MONOSTEARATE METHYLPARABEN POLYETHYLENE GLYCOL 600 POTASSIUM HYDROXIDE PROPYLENE GLYCOL PROPYLPARABEN 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.image description
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.In case of accidental ingestion, Keep out of reach of children. get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?
Storage and handling
Information about safe storage and handling of the drug product.•keep tightly closed Other information •store at room temperature 68° - 86° F (20° - 30°C).
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 •if you have sensitive skin or are sensitive to benzoyl peroxide When using this product •avoid contact with eyes, lips and mouth •avoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this product •with other topical acne medicaitons, at the same time nor immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medicaiton should be used unless directed by a doctor •skin irritaiton may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentration may aggravtae skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration •avoid unnecessary sun exposure and use a sunscreen Stop use and ask a doctor •if skin irritation becomes severe
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