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| Product NDC Code | 58228-2045 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone 1% |
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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 | ProStat First Aid 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 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 Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, 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.Use(s) 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 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 1% Hydrocortisone 1% GLYCERYL MONOSTEARATE METHYLCHLOROISOTHIAZOLINONE WATER TROLAMINE HYDROCORTISONE HYDROCORTISONE CETOSTEARYL ALCOHOL PROPYLENE GLYCOL STEARIC ACID 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.Label Hydrocortisone Cream USP 1% PS-2045-BX-MASTER
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 • In the rectum by using fingers or any mechanical device or applicator
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information • Store at room temperature 15º-30ºC (59º-86ºF) • Avoid excessive heat • Tamper Evident. Do not use if packet is torn, cut, or opened.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-900-2920 Monday - Friday, 8AM - 4PM PST.
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) • Bleeding occurs due to anal itching
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use
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 Exteranl 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 • In the rectum by using fingers or any mechanical device or applicator 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) • Bleeding occurs due to anal itching Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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