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| Product NDC Code | 71397-822 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne therapy |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 1548871 | ||||
| Application Number | M006 | ||||
| Labeler Name | menScience Androceuticals, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzoyl Peroxide 3% 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: Shake before using. Apply to clean skin. Cover the affected area with a thin layer 1 to 3 times daily. Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day. If going outside, allow product to dry, then use a sunscreen. Store at 20-25 C (68-77 F) o o
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua purificata (purified water), C12-15 Alkyl Benzoate, Urea, Butylene Glycol, Cyclopentasiloxane, Magnesium aluminum silicated, Steareth-20, Peg-100 stearate, Zea mays (corn) starch, Hydroxyethyl acrylate/sodium acryloydimethyl, Taurate copolymer, Squalane, Polysorbate 60, Chamomilla recutita (matricaria) extract, Camellia oleifera leaf extract, Phospholipids, Retinyl palmitate, Tocopherol, Ascorbyl palmitate, Beta-carotene, Ethylhexylglycerin, Cetearyl alcohol, Glycerin, Caprylyl glycol, Dimethicone, Acrylates/C10-30 alkyl acrylate crosspolymer, Steareth-2, Butylene Glycol, Propylene glycol, Panthenol, Disodium EDTA, Allantoin, Phytonadione.
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 and prevention 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.ACNE THERAPY BENZOYL PEROXIDE WATER ALKYL (C12-15) BENZOATE UREA BUTYLENE GLYCOL CYCLOMETHICONE 5 MAGNESIUM ALUMINUM SILICATE STEARETH-20 PEG-100 STEARATE STARCH, CORN HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) SQUALANE POLYSORBATE 60 MATRICARIA CHAMOMILLA CAMELLIA OLEIFERA LEAF LECITHIN, SOYBEAN VITAMIN A PALMITATE TOCOPHEROL ASCORBYL PALMITATE .BETA.-CAROTENE ETHYLHEXYLGLYCERIN CETOSTEARYL ALCOHOL GLYCERIN CAPRYLYL GLYCOL DIMETHICONE STEARETH-2 PROPYLENE GLYCOL PANTHENOL EDETATE DISODIUM ANHYDROUS ALLANTOIN PHYTONADIONE 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: Label
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 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.Discontinue use and ask a doctor if skin irritation becomes severe or if you are using more than one acne medication.
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: Apply to affected areas only. Avoid unnecessary sun exposure and use a sunscreen. Do not use in or near the eyes, lips or mouth. This product may bleach hair or dyed fabrics. Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin.
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 sensitive to benzoyl peroxide. When using this product: Apply to affected areas only. Avoid unnecessary sun exposure and use a sunscreen. Do not use in or near the eyes, lips or mouth. This product may bleach hair or dyed fabrics. Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. Discontinue use and ask a doctor if skin irritation becomes severe or if you are using more than one acne medication. 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