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Avene cleanance acne medicated clearing treatment - Medication Information

Product NDC Code 64760-776
Drug Name

Avene cleanance acne medicated clearing treatment

Type Brand
Active Ingredients
Benzoyl peroxide 5.5 mg/40ml
Route TOPICAL
Dosage Form LIQUID
Application Number M006
Labeler Name Pierre Fabre USA Inc.
Packages
Package NDC Code Description
64760-776-01 1 bottle in 1 carton (64760-776-01) / 5 ml in 1 bottle
64760-776-02 1 bottle in 1 carton (64760-776-02) / 40 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient BENZOYL PEROXIDE 5.5%

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.
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 dry of the skin may occur, start with one application daily, then gradually increase to two or three times daily 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.
Inactive Ingredients Water (aqua), propanediol, dimethyl isosorbide, glycerin, 1,2-hexanediol, acrylamide/sodium acryloyldimethyllurate copolymer, isohexadecane, hydroxyacetophenone, hylocereus undatus fruit extract, polysorbate 80, polyglyceryl-2 isostearate, xanthan gum, sodium citrate, trisodium ethylenediamine disuccinate, citric acid, diethylhexyl sodium sulfosuccinate, carbomer, sodium hydroxide, hyaluronic acid, ethylhexylglycerin, morinda citrifolia extract, phenoxyethanol, dimethicone, sodium metabisulfite, peg-40 stearate, silica, sorbitan stearate, tocopherol

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.
Uses For the treatment of acne. Dries and clears acne blemishes and allows skin to heal. Helps keep skin clear of new acne blemishes

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.
Avene Cleanance Acne Medicated Clearing Treatment BENZOYL PEROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE WATER PROPANEDIOL DIMETHYL ISOSORBIDE GLYCERIN 1,2-HEXANEDIOL SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) HYLOCEREUS UNDATUS FRUIT POLYSORBATE 80 XANTHAN GUM SODIUM CITRATE TRISODIUM ETHYLENEDIAMINE DISUCCINATE CITRIC ACID MONOHYDRATE SODIUM METABISULFITE CARBOMER 1342 SODIUM HYDROXIDE HYALURONIC ACID PHENOXYETHANOL DIMETHICONE PEG-40 STEARATE HYDRATED SILICA TOCOPHEROL HYDROXYACETOPHENONE MORINDA CITRIFOLIA FRUIT PEG-20 SORBITAN STEARATE ISOHEXADECANE POLYGLYCERYL-2 ISOSTEARATE DIHEXYL SODIUM SULFOSUCCINATE ETHYLHEXYLGLYCERIN

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.
Packaging EAU THERMALE AVENE LABORATORIE DERMATOLOGIQUE CLEANANCE ACNE MEDICATED CLEARING TREATMENT ACNE MEDICATED CREAM [BENZOYL PEROXIDE 5.5% FOR OILY, ACNE-PRONE, SENSITIVE SKIN REDUCES THE SEVERITY AND HELPS PREVENT NEW ACNE BLEMISHES, PIMPLES AND BLACKHEADS FROM FORMING 40 ML / 1.3 FL.OZ. Avene Cleanance Acne Medicated Clearing Treatment

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

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 or 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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions 1-866-41-AVENE (28363)

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 the 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, burning, itching, peeling, or possibly 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. Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide. 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 the 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, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor If irritation becomes severe Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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