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| Product NDC Code | 51824-050 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Careall 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 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | New World Imports, 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 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 itching of skin irritation, inflammation and rashes: 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 do not use. Ask a doctor. For external anal and genital itching, adults: adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toliet tissue or a soft cloth before applying. apply to affected area not more than 3 to 4 times daily. children under 12 years of age with external anal itching: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, 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 Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching 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.CAREALL Hydrocortisone Maximum Strength Hydrocortisone Hydrocortisone Acetate Hydrocortisone Propylene Glycol Petrolatum Mineral Oil Cetostearyl Alcohol CETETH-20 Chlorocresol Water White Cream
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.HYD Image
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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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 In the genital if you have a vaginal discharge. Consult a doctor When using this product: Avoid contact with the eyes Do not use more than directed unless told to do so 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, s ymptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs
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