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| Product NDC Code | 55681-224 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Procure |
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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 | OINTMENT | ||||||
| RxCUI drug identifier | 1440184 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | TWIN MED, 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 (per gram) Hydrocortisone Acetate, USP (1% w/w)
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 over 2 years of age Apply evenly to affected area no more than 3 to 4 times daily Children under 2 years of age Do not use, consult a doctor Adults- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly Gently dry, patting or blotting with bathroom tissue or soft cloth before applying apply externally to the area up to 6 times daily or after bowel movment After application, discard pad. Do not flush in toilet.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Cetomacrogol 1000, Cetostearyl Alcohol, Chloracresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.
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 For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Antipruritic (Anti-Itch)
Spl product data elements
Usually a list of ingredients in a drug product.procure Hydrocortisone Acetate CETETH-20 MINERAL OIL PETROLATUM CETOSTEARYL ALCOHOL EDETATE SODIUM PROPYLENE GLYCOL WATER SODIUM METABISULFITE CHLOROCRESOL HYDROCORTISONE ACETATE HYDROCORTISONE
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.Principal Display Panel Principal Display and Drug Fact Panel
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.Ask a doctor before use if you are pregnant or breast feeding
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 In the eyes for diaper rash if you have vaginal discharge more than recommended dosage.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at 20 o -25 o C(68 o -77 o F) Avoid excessive heat and humidity.
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 the condition worsens, or if symptoms persists 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. Do not use In the eyes for diaper rash if you have vaginal discharge more than recommended dosage. Ask a doctor before use if you are pregnant or breast feeding Stop use and ask a doctor if the condition worsens, or if symptoms persists for 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.
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