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Product NDC Code | 47682-933 | ||||
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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 | CREAM | ||||
RxCUI drug identifier | 106258 | ||||
Application Number | M017 | ||||
Labeler Name | Unifirst First Aid Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrocortisone 1.0%
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 over: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax
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 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 ALCOHOL METHYLPARABEN MINERAL OIL PARAFFIN PETROLATUM PROPYLPARABEN WATER WHITE WAX 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.Medi-First Plus Hydrocortisone MEDI-FIRST® Plus Hydrocortisone Cream 1% Temporary relief of itching associated with monor skin irritations, inflamation and rashes 25 units / Net Wt 0.9 g ( 1/32 oz) Item #93373 93373 MFP
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 clean the affected area store at room temperature (do not freeze) tamper evident, do notany opened or torn packets you may report a serious adverswe reaction to this product to 800-634-7680
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 teatment 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.
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 symptoms persist for more than 7 days symptoms clear up and occurs again within a few days
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 use of any other hydrocortisone product unless you've consulted a doctor
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 Do not use for the teatment of diaper rash. Consult a doctor When using this product avoid contact with the eyes do not begin use of any other hydrocortisone product unless you've consulted a doctor Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occurs again within a few days 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