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| Product NDC Code | 80861-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Oil free deep cleansing duo cleansing brush oil free acne cleanser |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 845836 | ||||
| Application Number | M006 | ||||
| Labeler Name | AcneFree, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzoyl peroxide 2.5% Purpose Acne treatment
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 • use every morning and evening • apply a dime-size amount to damp skin and gently massage, avoiding the eye area • rinse well • use wash on entire affected area one to two times daily • because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce cleansing 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. • may be used on chest or back
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP
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 treatment
Spl product data elements
Usually a list of ingredients in a drug product.Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne Cleanser BENZOYL PEROXIDE Oil Free Acne Cleanser BENZOYL PEROXIDE WATER GLYCERIN PROPYLENE GLYCOL COCAMIDOPROPYL HYDROXYSULTAINE SODIUM C14-16 OLEFIN SULFONATE XANTHAN GUM CITRIC ACID MONOHYDRATE POTASSIUM HYDROXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER SODIUM LAUROYL LACTYLATE GLYCOLIC ACID CERAMIDE NP CERAMIDE AP PHYTOSPHINGOSINE CHOLESTEROL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CERAMIDE 1 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.Package Labeling: Outer Package Inner Package
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 yo u • 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-768-2913
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 skin 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 yo u • have very sensitive skin • 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 skin 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