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Product NDC Code | 54108-8712 | ||||
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Drug Name | Derma e eczema relief |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 240464 | ||||
Application Number | M016 | ||||
Labeler Name | derma e | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Colloidal Oatmeal 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 Apply as needed to entire body, concentrating on areas of dryness
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Allantoin, Arctium Lappa Root Extract, Arctostaphylos Uva-Ursi Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower, Coco-Caprylate, Coptis Chinensis Root Extract, Dimethicone, Ethylhexylglycerin, Fagara Zanthoxyloides Fruit Extract, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Melia Azadirachta Leaf, Phenoxyethanol, Potassium Sorbate, Purified Water, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate.
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 Temporarily protects and helps relieve minor skin irritation and itching due to Eczema or Rashes
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Derma E Eczema Relief Oatmeal OATMEAL OATMEAL ALLANTOIN ARCTIUM LAPPA ROOT ARCTOSTAPHYLOS UVA-URSI LEAF MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CETYL ALCOHOL MATRICARIA CHAMOMILLA FLOWERING TOP COCO-CAPRYLATE COPTIS CHINENSIS ROOT DIMETHICONE ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL STEARATE SE GLYCERYL STEARATE CITRATE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE AZADIRACHTA INDICA LEAF PHENOXYETHANOL POTASSIUM SORBATE WATER JOJOBA OIL SODIUM HYDROXIDE STEARIC ACID D7 STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE, DL-
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.PRINCIPAL DISPLAY PANEL - 175 mL Tube Label THERAPEUTIC CLINICALLY TESTED Proven Clean Beauty™ DERMATOLOGIST • RECOMMENDED • DERMA • E Eczema Relief Lotion Neem, Burdock & Bearberry Extracts for dry skin symptoms associated with Psoriasis and Eczema 6 FL OZ / 175 mL PRINCIPAL DISPLAY PANEL - 175 mL Tube 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
Distributed by DERMA E ® Simi Valley, CA, 93065
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? Call toll free 1-800-933-9344 or visit dermae.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 Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days
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 Do not get into eyes
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 Do not get into eyes Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days 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