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| Product NDC Code | 67060-370 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone |
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| Type | Generic | ||||
| 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 | ADVANCED FIRST AID, 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 (in each gram)- Hydrocortisone USP 10mg
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 adults and children 2 years of age and older: apply to affected area 1 to 2 times daily. • Children under 2 years of age: do not use, consult a doctor. • Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years of age: for external anal itching, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: citric acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbate 80, propylene glycol, propyl paraben, purified water, sodium citrate and titanium dioxide.
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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes • 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.Antipruritic (Anti-Itch)
Spl product data elements
Usually a list of ingredients in a drug product.Hydrocortisone Hydrocortisone PROPYLENE GLYCOL WATER GLYCERYL MONOSTEARATE GLYCERIN PETROLATUM CITRIC ACID MONOHYDRATE HYDROCORTISONE 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.image description
image description
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.
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 Consult a doctor: • before use if you have a vaginal discharge (for external feminine itching) • for external itching, do not exceed the recommended daily dosage or if bleeding occurs • If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days When using this product: • avoid contact with eyes • do not put this product into rectum by using fingers or any mechanical device or applicator Do Not Use: • with 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