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| Product NDC Code | 57896-146 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone 1% |
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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 | ||||
| RxCUI drug identifier | 106258 | ||||
| Application Number | part348 | ||||
| Labeler Name | Geri-Care Pharmaceuticals, Corp | ||||
| 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 For Itching or skin irritation, inflammation, and rashes: Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use and ask a doctor. For External and anal itching in adults: When practical, clean 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 apply to affected area not more than 3 to 4 times daily. For children under 12 years of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.
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 and rashes ● external feminine, 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 Antipruritic (Anti-Itch)
Spl product data elements
Usually a list of ingredients in a drug product.Hydrocortisone 1% Hydrocortisone PHENOXYETHANOL MINERAL OIL GLYCERIN GLYCERYL MONOSTEARATE PETROLATUM WATER POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN 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.Gericare Hydrocortisone 0.9g CDER
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
Distributed By Distributed By Geri-Care Pharmaceuticals Corp 1295 Towbin Ave. Lakewood, NJ 08701
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 For the treatment of diaper rash, consult a doctor. With any other Hydrocortisone product unless you have consulted a doctor If you have a vaginal discharge, consult a doctor
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call 1-800-540-3765
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 using this product and ask a doctor if conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor. Rectal bleeding occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Avoid Contact with the eyes do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator.
Storage and handling
Information about safe storage and handling of the drug product.Other information ● store at controlled room temperature 20°-25°C ( 68 °- 77 °F) Tamper evident, do not use if packet is torn, cut or opened. Avoid excessive heat and humidity.
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
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