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| Product NDC Code | 83865-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Skinkure acne eraser spot 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 | SKINKURE, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid 2% 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 skin thoroughly. Apply spot treatment directly on blemish, avoiding the eye area. Do not rinse off.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, SD Alcohol 40-B (Alcohol Denat), Propanediol, Glycerin, Glycolic Acid, Mandelic Acid, Ammonium Acryloyldimethyltaurate/VPCopolymer, Niacinamide, SodiumHydroxide, 1,2-Hexanediol, Caprylyl Glycol, Morinda Citrifolia Extract, Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract, Arginine, Opuntia Ficus-Indica Stem Extract, Centella Asiatica Extract, Brassica Juncea Sprout Extract, Brassica Oleracea Botrytis Extract, Brassica Oleracea Capitata (Cabbage) Sprout Extract, Brassica Oleracea Gemmifera Extract, Wasabia Japonica Root Extract, Brassica Oleracea Italica (Broccoli) SproutExtract, Brassica Oleracea Acephala Sprout Extract, Dextrin, Polydextrose, Amylopectin, Garcinia Mangostana Fruit Extract, Withania Somnifera Root Extract, Foeniculum Vulgare (Fennel) Seed 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.Uses: This clear gel is applied to acne spots once to twice daily, can be used on all skin types.
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.Skinkure Acne Eraser Spot Treatment SALICYLIC ACID WATER PROPANEDIOL GLYCERIN GLYCOLIC ACID MANDELIC ACID AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER NIACINAMIDE SODIUM HYDROXIDE 1,2-HEXANEDIOL CAPRYLYL GLYCOL MORINDA CITRIFOLIA LEAF MELALEUCA ALTERNIFOLIA FLOWERING TOP ARGININE OPUNTIA FICUS-INDICA STEM CENTELLA ASIATICA TRITERPENOIDS WASABI ROOT BROCCOLI SPROUT POLYDEXTROSE GARCINIA MANGOSTANA FRUIT WITHANIA SOMNIFERA ROOT FENNEL SEED 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.83865-100 Outer Label Inner Label
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 on damaged or broken skin.
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 raight 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? Call (703) 712-6225 or visit www.skinkure.com
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 skin rash occurs.
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, keep out of eyes. Rinse with water to remove.
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 on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center raight 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