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| Product NDC Code | 68001-526 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone |
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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 | BluePoint Laboratories | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrocortisone Acetate 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 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 Antipruritic (Anti-Itch) HYDROCORTISONE ACETATE HYDROCORTISONE WHITE PETROLATUM SORBITAN SESQUIOLEATE MINERAL OIL
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.Label
Hydrocortisone Ointment, USP 1% Tube
Hydrocortisone Ointment, USP 1% carton
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 fingers or any mechanical device or applicator Ask a doctor before use if you are using any other hydrocortisone product
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? Contact 1-800-707-4621 Manufactured in India by: Gopaldas Visram & Company Limited Plot No. A327, T.T.C Indl. Area, M.I.D.C Mahape, Navi Mumbai - 400710. Mfg. Lic. No.: KD/503 For BluePoint Laboratories Rev 01/2022
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if Condition worsens, or if symptoms persist for 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
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 Preserve in well-closed container 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 fingers or any mechanical device or applicator Ask a doctor before use if you are using any other hydrocortisone product Stop use and ask a doctor if Condition worsens, or if symptoms persist for 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