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Product NDC Code | 58414-0017 | ||||
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Drug Name | Exuviance daily acne peel |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 251577 | ||||
Application Number | part333D | ||||
Labeler Name | NeoStrata Company Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 2%
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 medication Using a cotton pad, cover the affected area with a thin layer 1 to 3 times daily, avoiding eye area Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor If bothersome peeling or dryness occurs, reduce applications to once a day or every other day For new users, apply product sparingly with pad to 1 or 2 small affected areas for approximately 3 days. If no discomfort occurs, follow directions above Wash hands after applying Avoid sun exposure and use sunscreen daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alcohol Denat., Diisopropyl Adipate, Cyclopentasiloxane, Propylene Glycol, Triethyl Citrate, Cyclohexasiloxane, Citric Acid, Tartaric Acid, BHT.
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 Clears acne blemishes, acne pimples, blackheads and whiteheads Allows skin to heal Helps prevent new acne blemishes from forming
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.Exuviance Daily Acne Peel SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID ALCOHOL DIISOPROPYL ADIPATE CYCLOMETHICONE 5 TRIETHYL CITRATE PROPYLENE GLYCOL CYCLOMETHICONE 6 CITRIC ACID MONOHYDRATE TARTARIC ACID BUTYLATED HYDROXYTOLUENE
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.PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton exuviance ® FOCUS oily acne prone DAILY ACNE PEEL Clear blemishes, black/white-heads Formulated to smooth texture, reduce oiliness 2% Salicylic Acid acne solution Citric Acid and Tartaric Acid CitraFill 100 mL/3.4 fl oz PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
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 during pregnancy/lactation keep out of eyes Rinse with water to remove
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 Flammable- keep away from fire or flame
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? Call toll free 1-800-225-9411 (9am – 5pm ET)
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 Too much skin irritation or sensitivity develops or increases
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 Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. Only one medication should be used unless directed by a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 15°C-30°C (59°F – 86°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.Warnings For external use only Do not use during pregnancy/lactation keep out of eyes Rinse with water to remove When using this product Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. Only one medication should be used unless directed by a doctor Stop use and ask a doctor if Too much skin irritation or sensitivity develops or increases Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away Flammable- keep away from fire or flame
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