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| Product NDC Code | 81985-186 | ||||
|---|---|---|---|---|---|
| Drug Name | M3 naturals eczema 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 | ||||
| RxCUI drug identifier | 240651 | ||||
| Application Number | M016 | ||||
| Labeler Name | M3 Naturals 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 Colloidal Oatmeal 1% Purpose Skin Protectant
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 or older: Apply as needed Children under two-years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Organic Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Punica Granatum (Pomegranate) Extract, 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.Indications: 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.M3 NATURALS Eczema Cream OATMEAL ALLANTOIN ALOE VERA LEAF WATER SHEA BUTTER CALENDULA OFFICINALIS FLOWER CANNABIS SATIVA SEED OIL MEDIUM-CHAIN TRIGLYCERIDES CARTHAMUS TINCTORIUS FLOWER OIL CHAMOMILE CUCUMBER EMU OIL ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN GLYCERYL MONOSTEARATE LICORICE HELIANTHUS ANNUUS FLOWERING TOP PHENOXYETHANOL POMEGRANATE XANTHAN GUM OATMEAL OATMEAL
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.Package Labeling: 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:
Additional Information: for use on mild to moderate Eczema or as directed by physician. Store at room temperature.
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, consult physician.
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 for more than 7 days, or clear up and occur again within a few days.
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. Stop use and ask a doctor if: condition worsens, symptoms last for more than 7 days, or clear up and occur again within a few days. Keep out of reach of children. If swallowed, consult physician.
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