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| Product NDC Code | 81507-005 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dermeleve |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 1052684 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Advanced Derm Solutions 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 Pramoxine Hydrochloride (1%)
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 Ascorbyl Tetraispalmitate, Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 60, Propylene Glycol, Sodium Hyaluronate, Strontium Nitrate, Tocopherol Acetate (Vitamin E), Water, Xanthan Gum
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 temporary relief of pain and itching associated with skin irritations, minor burns, sunburn, and rashes due to poison ivy, poison oak, or poison sumac
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Dermeleve Pramoxine Hydrochloride ISOPROPYL MYRISTATE CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES CETOSTEARYL ALCOHOL DIMETHICONE 100 POLYACRYLIC ACID (450000 MW) HYALURONIC ACID PROPYLENE GLYCOL POLAWAX POLYSORBATE GLYCERIN CAPRYLYL GLYCOL XANTHAN GUM CERAMIDE NG WATER O-18 MAGNESIUM ALUMINUM SILICATE TYPE IA GLYCERYL STEARATE SE EDETATE DISODIUM TOCOPHEROL TETRAHEXYLDECYL ASCORBATE SHEA BUTTER PHENOXYETHANOL STRONTIUM NITRATE PRAMOXINE HYDROCHLORIDE PRAMOXINE
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
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.Store at 20-25ºC (68-77ºF). Keep carton for full product information
Questions? Visit www.dermeleve.com or call +1 (877)-684-2299
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