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Product NDC Code | 83524-407 | ||||
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Drug Name | Dermoia manuka honey 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 | TREASUREWISE LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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 Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Allantoin, Aloe Barbadensis Leaf (aloe Vera Gel) Juice, Arnica Montana Flower Extract, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceramide NG, Ceramide NP, Cetearyl Alcohol, Chamomilia Recutita (Chamomile) Extract, Citric Acid, dl-Panthenol, Ethylhexylglycerin, Euterpe Oleracea (Acai) Extract, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Isopropyl Myristate, Magnesium Aluminum Silicate, Manuka Honey, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Linum Usitatissimum (Flaxseed) Oil, Oryza Sativa (Rice) Bran Oil, Passiflora Incarnata (Passion Fruit) Extract, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Tocopheryl Acetate (Vitamin E), 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.Uses Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites
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.DERMOIA Manuka Honey Eczema Cream OATMEAL ALLANTOIN ALOE VERA LEAF ARNICA MONTANA FLOWER WATER SHEA BUTTER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CERAMIDE NG CERAMIDE NP CETOSTEARYL ALCOHOL CHAMOMILE CITRIC ACID MONOHYDRATE PANTHENOL ETHYLHEXYLGLYCERIN ACAI GLYCERIN GLYCERYL MONOSTEARATE HYALURONIC ACID ISOPROPYL MYRISTATE MAGNESIUM ALUMINUM SILICATE TEA TREE OIL NIACINAMIDE FLAX SEED RICE BRAN OIL AVOCADO OIL PHENOXYETHANOL JOJOBA OIL STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE 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
Other Information: Protect the product in this container from excessive heat and direct sun
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.
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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or beast-feeding, ask a health professional before use.
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 right away. If pregnant or beast-feeding, ask a health professional before use.
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