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Product NDC Code | 84234-000 | ||||
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Drug Name | Even keel resurfacing peel |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | M006 | ||||
Labeler Name | Personal Day Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Salicylic Acid 1.05% 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 After cleansing, cover the affected area with a thin layer one to two times per week. Because excessive drying of the skin may occur, start with one application (weekly), then gradually increase to two times weekly, if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to every other week.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Lactic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyacrylate Crosspolymer-6, Glycolic Acid, Glycerin, Oryza Sativa (Rice) Powder, Mandelic Acid, Potassium Azeloyl Diglycinate, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Sodium Hydroxide, Xanthan Gum, Sorbitan Isostearate, Citric Acid, Propanediol, Zinc Hydrolyzed Hyaluronate, t-Butyl Alcohol, Beta-Glucan
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 Treats acne Helps prevent the development of new acne blemishes
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.EVEN KEEL RESURFACING PEEL SALICYLIC ACID WATER LACTIC ACID AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) GLYCOLIC ACID GLYCERIN WHITE RICE MANDELIC ACID POTASSIUM AZELOYL DIGLYCINATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL HYDROXYACETOPHENONE SODIUM HYDROXIDE XANTHAN GUM SORBITAN ISOSTEARATE CITRIC ACID MONOHYDRATE PROPANEDIOL TERT-BUTYL ALCOHOL SALICYLIC ACID SALICYLIC ACID
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 - Carton Jar
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
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 immediately.
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? 1-888-404-3461
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.
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 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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