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Product NDC Code | 68726-359 | ||||||
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Drug Name | Pca skin intensive clarity treatment |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
RxCUI drug identifier | 346298 | ||||||
Application Number | M006 | ||||||
Labeler Name | CP Skin Health Group, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid (2.0%) 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 Cleanse 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 daily or every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Glycerin, PEG-12 Glyceryl Dimyristate, Cyclopentasiloxane, Isododecane, Niacinamide, Butylene Glycol, Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Isoamyl Laurate, Glyceryl Stearate, PEG-100 Stearate, Sodium Polyacrylate, Polysilicone-11, Bakuchiol, Caprylic/Capric Triglyceride, Maltodextrin, Phenoxyethanol, Coco-Caprylate/Caprate, Hexyl Resorcinol, Ethylhexyl Stearate, Retinol, Ethyl Linoleate, Polysorbate 20, Hexylresorcinol, Dipotassium Glycrrhizinate, Caprylyl Glycol, Trideceth-6, Xanthan Gum, Chlorphenesin, Pentylene Glycol, Isoamyl Cocoate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Sodium Citrate, Disodium EDTA, Decyl Glucoside, Myristoyl Nonapeptide-3, Citric Acid
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 of acne. Helps keep skin clear of new acne pimples, blackheads and/or whiteheads.
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.PCA SKIN Intensive Clarity Treatment SALICYLIC ACID WATER GLYCERIN PEG-12 GLYCERYL DIMYRISTATE CYCLOMETHICONE 5 ISODODECANE NIACINAMIDE BUTYLENE GLYCOL DIMETHICONE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER CETOSTEARYL ALCOHOL ISOAMYL LAURATE GLYCERYL MONOSTEARATE PEG-100 STEARATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SODIUM POLYACRYLATE (8000 MW) BAKUCHIOL MEDIUM-CHAIN TRIGLYCERIDES MALTODEXTRIN PHENOXYETHANOL COCO-CAPRYLATE RETINOL ETHYLHEXYL STEARATE ETHYL LINOLEATE HEXYLRESORCINOL POLYSORBATE 20 GLYCYRRHIZINATE DIPOTASSIUM CAPRYLYL GLYCOL XANTHAN GUM CHLORPHENESIN TRIDECETH-6 PENTYLENE GLYCOL ISOAMYL COCOATE SYRINGA VULGARIS FLOWER SODIUM CITRATE EDETATE DISODIUM DECYL GLUCOSIDE CITRIC ACID MONOHYDRATE MYRISTOYL PENTAPEPTIDE-4 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.ICTuc
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.
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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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