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| Product NDC Code | 72793-400 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mountain ice 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 | CREAM | ||||||
| RxCUI drug identifier | 240651 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Mountainside Medical Equipment, 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 Ingredients: Colloidal oatmeal 1%
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. Let product rest on the skin. Avoid drying soaps that can irritate the skin. Use daily for best results.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water (Aqua), Paraffinum Liquidum (Mineral) Oil, Stearyl Alcohol, Cetearyl Alcohol, Glycerin, Propylene Glycol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Polysorbate 60, Actinidia Chinensis (Kiwi) Seed Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Hydrolyzed Collagen, Retinyl Palmitate, Ceramide NP, Ceramide AP, Ceramide EOP, Lactic Acid, Sodium Lauroyl Lactylate, Phytosphingosine, Cholesterol, Zea Mays (Corn) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Origanum Vulgare (Oregano) Oil, Curcuma Longa (Turmeric) Root Oil, Carbomer, Xanthan Gum, Citric Acid, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol, Zinc Oxide (CI 77947).
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.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Mountain Ice Eczema Colloidal Oatmeal OATMEAL OATMEAL WATER MINERAL OIL STEARYL ALCOHOL CETOSTEARYL ALCOHOL GLYCERIN PROPYLENE GLYCOL POLYSORBATE 60 KIWI SEED OIL .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF HYALURONATE SODIUM VITAMIN A PALMITATE CERAMIDE NP CERAMIDE AP CERAMIDE 1 LACTIC ACID, UNSPECIFIED FORM SODIUM LAUROYL LACTYLATE PHYTOSPHINGOSINE CHOLESTEROL CORN OIL TEA TREE OIL OREGANO LEAF OIL TURMERIC OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE XANTHAN GUM CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN EDETATE DISODIUM ANHYDROUS SODIUM HYDROXIDE PHENOXYETHANOL ZINC OXIDE
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/Label Principal Display Panel – Tube Label MADE WITH SOLINE ® AND SK-INFLUX ® V MB TECHNOLOGY MOUNTAIN ICE ECZEMA CREAM COLLAGEN, HYALURONIC ACID, TURMERIC, KIWI SEED OIL, VITAMIN A, VITAMIN E, TEA TREE OIL, ZINC OXIDE, OREGANO OIL, SUNFLOWER OIL, COLLOIDAL OATMEAL, ALOE VERA, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP. 4 fl oz (118 g) Questions? 1-888-687-4334 Distributed by: Mountainside Medical 9262 Old River Road Marcy, New York 13403 Family Owned and Operated Service-Disabled Veteran image-01
Package/Label Principal Display Panel – Packet Label MOUNTAIN ICE ECZEMA CREAM MADE WITH SOLINE ® AND SK-INFLUX ® V MB TECHNOLOGY Net Wt. 4 grams www.MOUNTAIN-ICE.COM Distributed by: Mountainside Medical Marcy, New York 13403 image-02
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 the reach of children. If swallowed, seek medical attention 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: For use on mild to moderate eczema or as directed by a physician. Store at room temperature. Avoid freezing.
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 persist for 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 • avoid contact with 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 • avoid contact with eyes. Stop use and ask a doctor if • Condition worsens. • Symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out the reach of children. If swallowed, seek medical attention or contact a Poison Control Center immediately.
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