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Product NDC Code | 11090-223 | ||||||||
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Drug Name | La roche-posay effaclar duo dual action acne treatment |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
RxCUI drug identifier | 198503 | ||||||||
Application Number | part333D | ||||||||
Labeler Name | Beauty Manufacturing Solutions Corp | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzoyl Peroxide 5.5% Purpose Ance Medication
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.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 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 prdoucts and ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract
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.for the treatment of acne dries and clears acne blemishes and allows skin to heal
Purpose
Information about the drug product’s indications for use.Acne medication
Spl product data elements
Usually a list of ingredients in a drug product.La Roche-Posay Effaclar Duo Dual Action Acne Treatment Benzoyl Peroxide EDETATE DISODIUM ANHYDROUS ALPHA-TOCOPHEROL ACETATE SILICON DIOXIDE GLYCERIN ISOSTEARYL ALCOHOL EPILOBIUM ANGUSTIFOLIUM WHOLE BENZOYL PEROXIDE BENZOYL PEROXIDE CAPRYLOYL SALICYLIC ACID CARBOMER COPOLYMER TYPE A WATER POTASSIUM HYDROXIDE CARBOMER INTERPOLYMER TYPE A (55000 CPS) PENTYLENE GLYCOL
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.Principle Display Panel
Principle Display Panel
Principle Display Panel
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.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.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.1-888-LRP-LABO 1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)
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.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.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
Storage and handling
Information about safe storage and handling of the drug product.store at 20 - 25 C (68 to 77 F)
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.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