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Hydrocortisone - Medication Information

Product NDC Code 47682-211
Drug Name

Hydrocortisone

Type Generic
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 106258
Application Number M017
Labeler Name Unifirst First Aid Corporation
Packages
Package NDC Code Description
47682-211-12 10 pouch in 1 box (47682-211-12) / .9 g in 1 pouch (47682-211-99)
47682-211-35 144 pouch in 1 box (47682-211-35) / .9 g in 1 pouch (47682-211-99)
47682-211-73 25 pouch in 1 box (47682-211-73) / .9 g in 1 pouch (47682-211-99)
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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 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 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, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes 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 Hydrocortisone Label MEDI-FIRST ® 1% Hydrocortisone Cream Temporary relief of itching associated with minor skin irritation, inflammation and rashes Product # 24369 10 units of 0.9gm (1/32oz) Packets 24369 Medi First® Plus Hydrocortisone Cream 1% Temporary releif of itching associated with minor skin irritation, inflamation and rashes 25 units / Net Wt 0.9 g (1/32 oz) Item #93373 93373 Hydro

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 (donot freeze) tamper evident, do not use any opened or torn packets

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 with anyother Hydrocortisone product unless you have consulted adoctor if you have vaginal discharge, consulkt 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 or Comments? 1-800-634-7680

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 with anyother Hydrocortisone product unless you have consulted adoctor if you have vaginal discharge, consulkt a doctor 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 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