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Product NDC Code | 49967-024 | ||||||
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Drug Name | La roche posay laboratoire dermatologique effaclar clarifying |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | SOLUTION | ||||||
RxCUI drug identifier | 199308 | ||||||
Application Number | M006 | ||||||
Labeler Name | L'Oreal USA Products Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 0.5%
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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, alcohol denat., propanediol, glycolic acid, sodium hydroxide, capryloyl glycine, phenoxyethanol, benzyl alcohol, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, menthol, tremella fuciformis polysaccharide, butylene glycol, ophiopogon japonicus root extract, scutellaria baicalensis root 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.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.La Roche Posay Laboratoire Dermatologique Effaclar Clarifying Salicylic Acid SALICYLIC ACID SALICYLIC ACID water ALCOHOL PROPANEDIOL GLYCOLIC ACID SODIUM HYDROXIDE CAPRYLOYL GLYCINE PHENOXYETHANOL BENZYL ALCOHOL PPG-26-BUTETH-26 MENTHOL BUTYLENE 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.image of a label
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? 1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)
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.
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.Other information Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
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
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