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| Product NDC Code | 72113-109 | ||||
|---|---|---|---|---|---|
| Drug Name | Evereden intensive eczema balm |
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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 | OINTMENT | ||||
| Application Number | M016 | ||||
| Labeler Name | Eden Brands 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.Colloidal Oatmeal 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: Use as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Helianthus Annuus (Sunflower) Seed Oil, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Vegetable Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Butter, Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Spent Grain Wax, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Phaeodactylum Tricornutum Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Argania Spinosa Kernel Oil, Hydrogenated Vegetable Oil, Beta-Sitosterol, Boswellia Serrata Gum, Oleic Acid, Linoleic Acid, Phytosterols, Phospholipids, Glyceryl Behenate, Saccharomyces/Zinc Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Iron Ferment, Saccharomyces/Silicon Ferment, Saccharomyces/Copper Ferment, Polyglyceryl-4 Isostearate, Lecithin, Polyglyceryl-3 Diisostearate, Ceramide NG, Ceramide NP, Water (Aqua), Rosmarinus Officinalis (Rosemary) Leaf Extract, Quercetin, Tocopherol
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 Rashes
Purpose
Information about the drug product’s indications for use.Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Evereden Intensive Eczema Balm Colloidal Oatmeal POLYHYDROXYSTEARIC ACID (2300 MW) CANDELILLA WAX RIBES NIGRUM SEED OIL LECITHIN, SUNFLOWER PHAEODACTYLUM TRICORNUTUM HELIANTHUS ANNUUS SEED WAX OCTYLDODECANOL ISOSTEARYL ALCOHOL SUNFLOWER OIL UNSAPONIFIABLES OATMEAL OATMEAL POLYGLYCERYL-4 ISOSTEARATE WATER C18-38 ALKYL HYDROXYSTEAROYL STEARATE .BETA.-SITOSTEROL INDIAN FRANKINCENSE TOCOPHEROL CERAMIDE NP ROSEMARY SUNFLOWER OIL JOJOBA OIL SQUALANE CARDIOSPERMUM HALICACABUM LEAF CORN OIL MEDIUM-CHAIN TRIGLYCERIDES JOJOBA BUTTER SHEA BUTTER ARGAN OIL OLEIC ACID LINOLEIC ACID OMEGA-3 FATTY ACIDS GLYCERYL DIBEHENATE POLYGLYCERYL-3 DIISOSTEARATE CERAMIDE NG QUERCETIN PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE COCONUT OIL
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.Eczema Balm Carton
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 right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: Store product at room temperature
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: Conditions worsen 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.For external use only
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