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| Product NDC Code | 79503-103 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone 1% |
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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 | Ezricare 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 Hydrocortisone Acetate 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 • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor. • When used for anal itching, 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. Children under 12: consult a doctor before using for anal itching.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Mineral Oil, Sorbitan Sesquioleate, White Petrolatum
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, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching
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.Hydrocortisone 1% Hydrocortisone Acetate HYDROCORTISONE ACETATE HYDROCORTISONE MINERAL OIL SORBITAN SESQUIOLEATE WHITE PETROLATUM
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 Ezricare-103
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 Ointment Compared to the active ingredient in Cortizone •10 ®* Temporary Relief the Discomfort of Itching, Rashes and Irritation on Skin Due to Eczema, Psoriasis and Insect bites *This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortizone • 10 ® Distributed by: EzriCare, LLC Lakewood, NJ www.EzriCare.com Made in India
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.
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? 718-502-6610 between 9 am to 4 pm EST, Monday-Friday.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • Avoid excessive heat • See crimp of tube or carton for Lot Number and Expiry 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 If pregnant or breast-feeding , ask a health professional before use Do not use • in the eyes • for diaper rash • for external genital or feminine itching if you have a vaginal discharge • more than the recommended daily dosage unless directed by a doctor • this product in the rectum by using finger or any mechanical device or applicator Stop use and ask a doctor if • condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching 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