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| Product NDC Code | 69396-003 | ||||||||
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| 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 | OINTMENT | ||||||||
| RxCUI drug identifier | 203105 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | TRIFECTA PHARMACEUTICALS USA LLC | ||||||||
| Packages |
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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 ●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 a soft cloth before applying ●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily ●children under 12 years of age: Do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Light Mineral Oil, 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 temporary relieves itching associated with minor skin irritations, inflammation and rashes due to: ● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps ●detergents ● cosmetics ● jewelry ●external genital 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 HYDROCORTISONE LIGHT MINERAL OIL PETROLATUM 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.Packaging hydrocortisone
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.Distributed by: Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301, USA 1-888-296-9067
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 immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other Information to open: unscrew cap and pull tab to remove foil seal if seal has been broken, do not use this product. Return product to the Store where you bought it store at controlled room temperature 15°-30°C (59°- 86°F) see carton or tube 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 ●avoid contact with the eyes ●do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop using this product and ask a doctor ● in case of bleeding if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product. Do not use this product and ask a doctor ● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age. For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor ● in case of bleeding, consult a doctor promptly ● do not put this product into the rectum by using fingers or any mechanical device or applicator ● children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton. It contains important information.
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