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Hydrocortisone with aloe - Medication Information

Product NDC Code 63187-504
Drug Name

Hydrocortisone with aloe

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 1 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 106258
Application Number M017
Labeler Name Proficient Rx LP
Packages
Package NDC Code Description
63187-504-01 1 tube in 1 carton (63187-504-01) / 28.4 g in 1 tube
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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 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, cleanse the 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 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 aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol

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 • temporary relief of itching associated with minor skin irritations and rashes due to o eczema o insect bites o poison ivy, poison oak, or poison sumac o soaps o detergents o cosmetics o jewelry o seborrheic dermatitis o psoriasis o external 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 Anti-itch cream

Spl product data elements

Usually a list of ingredients in a drug product.
Hydrocortisone with Aloe Hydrocortisone Hydrocortisone Hydrocortisone CETOSTEARYL ALCOHOL SODIUM CETOSTEARYL SULFATE SODIUM LAURYL SULFATE CITRIC ACID MONOHYDRATE GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL PARAFFIN PROPYLPARABEN WATER STEARYL ALCOHOL

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 - 28.4 g Tube Carton Itch and Rash Relief MAXIMUM STRENGTH Hydrocortisone 1% Cream Antipruritic (Anti-Itch) With Aloe NET WT 1 oz (28.4 g) 63187-504-01

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: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have • a vaginal discharge • rectal bleeding • diaper rash

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 • in the eyes • by putting this product into the rectum by using fingers or any mechanical device or applicator

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? Call 1-866-923-4914

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 gets worse • condition persists for more than 7 days • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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 consult a doctor before exceeding recommended dosage

Storage and handling

Information about safe storage and handling of the drug product.
Other information • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube • store at room temperature • see carton or tube crimp for lot number and expiration date

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 • in the eyes • by putting this product into the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you have • a vaginal discharge • rectal bleeding • diaper rash When using this product consult a doctor before exceeding recommended dosage Stop use and ask a doctor if • condition gets worse • condition persists for more than 7 days • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor. 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