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| Product NDC Code | 69473-017 | ||||
|---|---|---|---|---|---|
| Drug Name | Alumier md intensive recovery |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 106258 | ||||
| Application Number | part348 | ||||
| Labeler Name | Alumier Labs | ||||
| 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 Hydrocortisone 1.0%
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 2 years of age and older, apply sparingly to affected area not more than three to four times daily do not use on children under 2 years of age, consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, Propanediol, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Butylene Glycol, Behenyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Sodium Acrylates Copolymer, Niacinamide, Aloe Barbadensis Leaf Juice, Hinokitiol, Resveratrol, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Anthemis Nobilis Flower Extract, Sea Whip Extract, Boswellia Serrata Extract, Honey Extract (Extrait de Miel), Tetrapeptide-14, Copper Tripeptide-1, Camellia Sinensis Leaf Extract, Aspalathus Linearis (Rooibos) Extract, Eucalyptus Globulus Leaf Extract, Mentha Viridis (Spearmint) Extract, Pogostemon Cablin Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Hydrogenated Lecithin, Squalane, Lecithin, Xanthan Gum, Caprylic Acid, Pentylene Glycol, Isosqualane, Sodium Methyl Stearoyl Taurate, Tricaprylin, Polymethyl Methacrylate, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Ethylhexylglycerin.
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 adults and children 2 years of age and older: For the temporary relief of minor skin irritations, rashes, itching and redness due to eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (e.g. caused by soaps, detergents, cosmetics and/or jewelry), seborrheic dermatitis, psoriasis.
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch cream
Spl product data elements
Usually a list of ingredients in a drug product.Alumier MD Intensive Recovery Hydrocortisone DOCOSANOL LECITHIN, SOYBEAN TRICAPRYLIN CAPRYLYL GLYCOL XYLITOL HONEY EUCALYPTUS GLOBULUS LEAF MENTHA SPICATA HYDROGENATED SOYBEAN LECITHIN EDETATE DISODIUM EDETIC ACID SODIUM HYDROXIDE HYDROCORTISONE HYDROCORTISONE JOJOBA OIL BUTYLENE GLYCOL WATER SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN DIMETHICONE PROPANEDIOL COCOA BUTTER ALOE VERA LEAF NIACINAMIDE .BETA.-THUJAPLICIN RESVERATROL PREZATIDE COPPER LAVANDULA ANGUSTIFOLIA FLOWERING TOP CHAMAEMELUM NOBILE FLOWER PSEUDOPTEROGORGIA ELISABETHAE INDIAN FRANKINCENSE APPLE ROSEMARY CRANBERRY PENTYLENE GLYCOL GREEN TEA LEAF ASPALATHUS LINEARIS WHOLE SQUALANE ETHYLHEXYLGLYCERIN XANTHAN GUM CAPRYLIC ACID SODIUM METHYL STEAROYL TAURATE POLY(METHYL METHACRYLATE; 450000 MW)
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.Product Packaging - 236 mL Alumier MD Intensive Recovery Anti-Itch Cream NPN 80065215 236 mL / 8 fl oz intensive recovery rev
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
Company Information Alumier MD ALUMIER EUROPE LTD. 5 ST. FREDERICK STREET VALLETTA VLT 1470, MALTA WWW.ALUMIERMD.COM EUROPE • UNITED STATES • CANADA UNITED KINGDOM DISTRIBUTED IN CANADA BY ALUMIER LABS INC., 436 LIMESTONE CRESCENT TORONTO, ON, M3J 2S4 DISTRIBUTED IN THE USA BY ALUMIER LABS INC., 550 COCHITUATE ROAD, SUITE 25 FRAMINGHAM, MA 01701 MANUFACTURED IN CANADA UNDER LICENSE FROM ALUMIER EUROPE LTD.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.do not use for the treatment of diaper rash, except on the advice of a physician
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, call a Poison Control Centre or get medical help 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 Do not use if security seal is broken or missing. You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 550 Cochituate Road, Suite 25, Framingham, MA 01701
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 or if symptoms persist for more than 7 days or clears up and occurs again within a few days. Do not begin use of any other hydrocortisone product unless directed by a physician.
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, do not use in or around the 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. do not use for the treatment of diaper rash, except on the advice of a physician When using this product avoid contact with eyes, do not use in or around the eyes Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. Do not begin use of any other hydrocortisone product unless directed by a physician. Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.
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