Purpose
Acne Treatment
Avene Cleanance Acne Medicated Clearing Treatment Liquid
FDA Label NDC 64760-776
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pierre Fabre Usa Inc. for the product Avene Cleanance Acne Medicated Clearing Treatment (NDC 64760-776). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, active ingredient, uses, warnings, do not use if you, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
BENZOYL PEROXIDE 5.5%
Uses
For the treatment of acne.
Dries and clears acne blemishes and allows skin to heal.
Helps keep skin clear of new acne blemishes
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.
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 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
Questions
1-866-41-AVENE (28363)
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.
* Please review the disclaimer below.
