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| Product NDC Code | 79503-202 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone cream 1% with aloe vera |
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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 | M017 | ||||
| Labeler Name | Ezricare Llc | ||||
| Packages |
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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 • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily. • children under 2 years: ask a doctor • For external anal itching in adults: • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad • gently dry by patting or blotting with toilet tissue or soft cloth before applying • for external anal itching in children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Vera Leaf, Cetostearyl Alcohol, Glyceryl Stearate SE, Methylisothiazolinone, Propylene Glycol, Water, Stearic Acid, Trolamine, 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 the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:• eczema • seborrheic dermatitis • psoriasis • Insect bites • poison ivy, poison oak, and poison sumac • cosmetics • jewelry • detergents • soaps • temporarily relieves external anal and genital 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 Cream 1% with Aloe Vera Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF CETOSTEARYL ALCOHOL GLYCERYL STEARATE SE METHYLISOTHIAZOLINONE PROPYLENE GLYCOL WATER STEARIC ACID TROLAMINE 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-202
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 Compared to the active ingredient in Cortizone 10® *Cortizone 10®* *This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortisone 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 • for the treatment of diaper rash. Ask a doctor. • for external genital itching if you have a vaginal discharge. Ask a doctor. • for external anal itching if rectal bleeding occurs. Consult a doctor promptly. When using this product • do not get into the eyes • for external anal itching, do not use more than directed, unless told so by a doctor. • do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product. Keep out of the 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