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| Product NDC Code | 42673-009 | ||||
|---|---|---|---|---|---|
| Drug Name | Epionce renewal calming cream |
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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 | CREAM | ||||
| Application Number | part347 | ||||
| Labeler Name | Episciences, Inc. | ||||
| 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 Colloidal Oatmeal 0.03%
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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Petrolatum, Meadowfoam Seed Oil, Safflower Oil, PPG-2 Myristyl Ether Propionate, Hydrogenated Polybutene (1300MW), Cyclomethicone 5, Rosa Canina Fruit Oil, White Wax, Gluconolactone, Allium Fistulosum Bulb, Alteromonas Ferment Filtrate, Apple, Arachidyl Alcohol, Arachidyl Glucoside, Butylene Glycol, C10-30 Cholesterol/Lanosterol Esters, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Carboxypolymethylene, Ceramide 1, Ceramide AP, Ceramide NP, Cetearyl Glucoside, Cetostearyl Alcohol, Cetyl Alcohol, Cholesterol, Cyclomethicone 4, Cyclomethicone 6, Dimethiconol (14000 CST), Docosanol, Edetate Disodium, Glyceryl Monostearate, Levomenol, Magnesium Salicylate, Magnesium Stearate, Manganese Gluconate, Meadowfoam Estolide, Nymphaea Alba Flower, PEG-100 Stearate, Phytosphingosine, Sodium Benzoate, Sodium Lauroyl Lactylate, Sodium Palmitoyl Proline, Trolamine, Xanthan Gum, Zinc Stearate.
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: rashes eczema
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.Epionce Renewal Calming Cream OATMEAL PETROLATUM MEADOWFOAM SEED OIL CETOSTEARYL ALCOHOL SAFFLOWER OIL HYDROGENATED POLYBUTENE (1300 MW) MAGNESIUM STEARATE GLYCERIN WATER ARACHIDYL ALCOHOL BUTYLENE GLYCOL C10-30 CHOLESTEROL/LANOSTEROL ESTERS OATMEAL OATMEAL PPG-2 MYRISTYL ETHER PROPIONATE CERAMIDE AP CERAMIDE NP ROSA CANINA FRUIT OIL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOXYPOLYMETHYLENE CETYL ALCOHOL DOCOSANOL GLYCERYL MONOSTEARATE PEG-100 STEARATE SODIUM BENZOATE SODIUM LAUROYL LACTYLATE WHITE WAX ALLIUM FISTULOSUM BULB APPLE ARACHIDYL GLUCOSIDE CETEARYL GLUCOSIDE CHOLESTEROL GLUCONOLACTONE CERAMIDE 1 EDETATE DISODIUM EDETIC ACID LEVOMENOL MAGNESIUM SALICYLATE MANGANESE GLUCONATE MANGANESE CATION (2+) NYMPHAEA ALBA FLOWER PHYTOSPHINGOSINE SODIUM PALMITOYL PROLINE PROLINE TROLAMINE XANTHAN GUM ZINC STEARATE PHENOXYETHANOL TRISILOXANE
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.Epionce Essential Recovery Kit Principal Display Panel Essnetial Recovery Kit PDP
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll free 1-866-374-6623
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 product is 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