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Product NDC Code | 68093-5105 | ||||
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Drug Name | Mg217 baby eczema |
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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 | ||||
Application Number | part347 | ||||
Labeler Name | Wisconsin Pharmacal Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Colloidal Oatmeal (Oat Kernel Flour) 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 Apply as needed, especially after bathing. Massage thoroughly into skin as colloidal oatmeal is slow to absorb.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Purified Water, Cetyl Alcohol, Glycerin, Cetearyl Alcohol, Dicetylphosphate, Ceteth-10 Phosphate, Isopropyl Myristate, Persea Gratissima (Avocado) Oil, Glucono Delta Lactone, Glyceryl Monolaurate, D-Panthenol, Xanthan Gum, Hydroxypropyl Bispalmitamide MEA, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Palmitic Acid, Conjugated Linoleic Acid, Cholesterol, Euphorbia Cerifera (Candelilla) Wax, Phenoxyethanol, Ethylhexyl Glycerin, Allantoin, Glycyrrhizic Acid, Sodium Benzoate, Sodium Hydroxide, Menthol, Disodium EDTA
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 rash dermatitis
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.MG217 Baby Eczema Colloidal Oatmeal CETYL ALCOHOL ETHYLHEXYLGLYCERIN ALLANTOIN GLYCYRRHIZIN GLYCERYL 1-LAURATE HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE SODIUM HYDROXIDE HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE DEXPANTHENOL GLUCONOLACTONE CETOSTEARYL ALCOHOL DIHEXADECYL PHOSPHATE OATMEAL OATMEAL CANDELILLA WAX CETETH-10 PHOSPHATE EDETATE DISODIUM EDETIC ACID WATER MENTHOL, (+)- ISOPROPYL MYRISTATE AVOCADO OIL SODIUM BENZOATE GLYCERIN XANTHAN GUM PALMITIC ACID CONJUGATED LINOLEIC ACID CHOLESTEROL PHENOXYETHANOL
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.Tube Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop using and ask doctor if: condition worsens symptoms last more than 7 days or clear up and occur again wtihin a few days
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Keep cap tightly closed when not in use. Store at room temperature.
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? 1-800-635-3696
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