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Product NDC Code | 81507-002 | ||||||||||
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Drug Name | Dermeleve |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | CREAM | ||||||||||
RxCUI drug identifier | 2531532, 2603409 |
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Application Number | M016 | ||||||||||
Labeler Name | Advanced Derm Solutions LLC | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Aluminum acetate (0.2%)
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 Adults and children two years of age and older, apply to affected area as needed or as directed by a doctor. Consult a doctor for children under the age of two.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Strontium Nitrate, Isopropyl Myristate, Butyrospermum Parkii (shea) Butter, Caprylyc/Capric Triglyceride, Cetearyl Alcohol, Emulsifying Wax NF, Glycerin, Phenoxyethanol, Magnesium Aluminum Silicate, Glyceryl Stearate, Dimethicone, Polyacrylate Crosspolymer-6, Xanthan Gum, Caprylyl Glycol, Sodium Hyaluronate, Disodium EDTA, Ceramide NG, Tocopherol (Vitamin E), Tetrahexyldecyl Ascorbate
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 • Insects Bites • Minor Burn • Athlete's foot • Poison lvy • Poison oak • Poison sumac • Rashes cause by soaps, detergents, cosmetic or jewelry
Purpose
Information about the drug product’s indications for use.Purpose Astringent
Spl product data elements
Usually a list of ingredients in a drug product.Dermeleve Aluminum Acetate CERAMIDE NG GLYCERYL MONO- AND DICAPRYLOCAPRATE CETYL ALCOHOL POLYACRYLIC ACID (450000 MW) HYALURONIC ACID CAPRYLYL GLYCOL DIMETHICONE 100 EDETATE DISODIUM GLYCERIN GLYCERYL STEARATE SE ISOPROPYL MYRISTATE MAGNESIUM ALUMINUM SILICATE TYPE IA STEARYL ALCOHOL PHENOXYETHANOL POLAWAX POLYSORBATE SHEA BUTTER STRONTIUM NITRATE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL WATER O-18 XANTHAN GUM ALUMINUM ACETATE ALUMINUM CATION
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.Product label image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description
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.Questions ? Visit www.dermeleve.com
Manufactured for Advanced Derm Solutions LLC Ocala, FL 34482 | dermeleve.com U.S. Patents: 5,716,625; 5,804,203; 6,139,850; 7,404,967
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. ■ Avoid contact with eyes. ■ Do not apply to open wounds. ■ STOP USE and ask a doctor if condition worsens or symptoms persist for more than seven days. ■ Keep out of reach of children.
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