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Acne treatment - Medication Information

Product NDC Code 69842-646
Drug Name

Acne treatment

Type Brand
Active Ingredients
Benzoyl peroxide 1 mg/g
Route TOPICAL
Dosage Form GEL
Application Number M006
Labeler Name CVS Pharmacy
Packages
Package NDC Code Description
69842-646-10 1 tube in 1 package (69842-646-10) / 28 g in 1 tube
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Adverse reactions

Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
Adverse Reactions Section This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear and persa-gel 10 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2020 CVS/pharmcay CVS.com 1-800-SHOP CVS

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 clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily 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 daily 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 carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, 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 medication

Spl product data elements

Usually a list of ingredients in a drug product.
Acne Treatment Benzoyl peroxide CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) EDETATE DISODIUM HYPROMELLOSES LAURETH-4 SODIUM HYDROXIDE 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 CVS Health MAXIMUM STRENGTH Acne Treatment Gel 10% BENZOLY PEROXIDE ACNE MEDICANTION PARABEN - PHTHALATE FREE NET WT 1 OZ (28 g) PACKAGE CONTAINS ONE TUBE NOT ACTUAL SIZE NET WT 1 OZ (28 g) 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.
Claims CVS Health Acne Treatment Gel contains maximum strength benzoyl peroxide. The micronized benzoyl peroxide formula goes to work immediately, releasing the medicine deep into the pores where pimples begin

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 have very sensitive skin 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.

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.
stop use and ask a doctor if irritation becomes severe

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 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 avoid unnecessary sun exposure and use a sunscreen avoid contact with eyes, lips and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, buring, itching, peeling or posible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

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

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