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| Product NDC Code | 70403-923 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone maximum strength |
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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 | Aru Pharma 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 ingredient Hydrocortisone USP 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 For minor skin irritations and rashes , adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. For external anal itching: • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product • Children: under 12 years of age, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cetostearyl Alcohol, Cetomacrogol 1000, Paraffin Wax, Micro Crystalline Wax, Propylene Glycol, Light Liquid Paraffin, Mono basic Sodium Phosphate, Propyl Paraben, Methyl Paraben, Chlorocresol, Purified Water
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 itching associated with minor skin irritations and rashes due to: • Eczema • Insect bites • Soaps and detergents • Cosmetics • Jewelry • Seborrheic dermatitis • Psoriasis • Poison ivy, oak or sumac • For external genital, 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 Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.HYDROCORTISONE MAXIMUM STRENGTH Hydrocortisone HYDROCORTISONE HYDROCORTISONE CETOSTEARYL ALCOHOL CETETH-20 PARAFFIN MICROCRYSTALLINE WAX PROPYLENE GLYCOL LIGHT MINERAL OIL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PROPYLPARABEN METHYLPARABEN CHLOROCRESOL WATER white to off white
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.Packaging Hydrocroz1
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
MAXIMUM STRENGTH ANTI-ITCH CREAM Temporary Relief the Discomfort of itching, Rashes and Irritation on Skin Due to Eczema, Psoriasis and Insect bites Compared to the active ingredient in Cortizone 10 Distributed by. ARU PHARMA INC. MOUNT VERNON, NY 10552 www.qpackrx.com
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. (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1 844 500-2729 between 9 am and 4 pm EST, Monday to Friday.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date
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 children under 2 years of age • If you have a vaginal discharge • For the treatment of diaper rash Ask a doctor before use if you have • External genital or feminine itching • External anal itching • Bleeding When using this product • Avoid contact with eyes • Do not exceed the recommended daily dosage unless directed by a doctor • Do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product, unless you have consulted a doctor.
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