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| Product NDC Code | 47682-397 | ||||||
|---|---|---|---|---|---|---|---|
| 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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| Check if available Online | Get Medication Prices online with Discount |
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 for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily children under 12 years of age: for external anal itching, consult a doctor children under 2 years of age: do not use, consult a doctor adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad gently dry by patting or botting with toilet tissue or a soft cloth before application of this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient emulsifying wax, ethanoll, 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 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 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.Green Guard Hydrocortisone Label Maximum Strength Hydrocortisone cream 1% Temporary relief of itching associated with minor skin irritation, inflammation and rashes Green Guard Order # 3103 25 Per Box Net Wt 0.9 g (1/32 oz) Packets 3103
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 for the treatment of diaper rash in eyes for feminine itching
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.
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 (do not freeze) tamper evident, do not use any opened or torn packets
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-869-6970
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 lasts more than 7 days, or clears and occurs again within a few days you begin use of any other Hydrocortisone product unless you have consulted a doctor bleeding occurs
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 treatment of diaper rash in eyes for feminine itching Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears and occurs again within a few days you begin use of any other Hydrocortisone product unless you have consulted a doctor bleeding occurs
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