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| Product NDC Code | 68016-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone maximum strength |
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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 | M017 | ||||
| Labeler Name | Chain Drug Consortium, 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 • do not use, consult a doctor For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax. May contain citric acid or sodium citrate solution to adjust pH.
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 •jewelry •detergents •cosmetics •psoriasis •seborrheic dermatitis •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.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Hydrocortisone Maximum Strength Hydrocortisone HYDROCORTISONE HYDROCORTISONE CETYL ALCOHOL GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE METHYLPARABEN POLYOXYL 40 STEARATE POLYSORBATE 60 PROPYLENE GLYCOL PROPYLPARABEN WATER SORBIC ACID SORBITAN MONOSTEARATE STEARYL ALCOHOL WHITE WAX
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.PRINCIPAL DISPLAY PANEL Premier Value ® COMPARE TO THE ACTIVE INGREDIENT IN CORTIZONE•10 ® * MAXIMUM STRENGTH Hydrocortisone Cream, USP 1% ANTI-ITCH CREAM Relieves Itches and Rashes For the temporary relief of itching associated with minor skin irritations, inflammation and rashes NET WT 1 OZ (28g) Hydrocortisone Cream, USP 1%
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
Other information Store at room temperature 59°-86°F (15°-30°C). Protect from freezing. Before using any medication, read all label directions. Keep carton, it contains important information.
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 external feminine itching if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. 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 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? 1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.
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 •symptoms last for more than 7 days •the condition gets worse •symptoms clear up and occur again in a few days •rectal bleeding occurs, consult doctor promptly
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 begin the use of any other hydrocortisone product unless directed by a doctor •for external anal itching: •do not use more than directed unless directed by a doctor •do not put this product into the rectum by using fingers or any mechanical device or applicator
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