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Hydrocortisone with aloe - Medication Information

Product NDC Code 50090-7428
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
Application Number M017
Labeler Name A-S Medication Solutions
Packages
Package NDC Code Description
50090-7428-0 1 tube in 1 box (50090-7428-0) / 28 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 and older apply to affected area not more than 3 to 4 times daily. Children under 2 years of age D o not use, consult a doctor For External and anal itching When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with toilet tissue or a soft cloth before application of this product. adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily children under 12 years of age with external anal itching: consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Edetate Disodium, Methylparaben, Mineral Oil, Mono and di glycerides, petrolatum, Polysorbate 60, Propylene glycol, propylparaben, purified water, sorbitan monostearate.

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 temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, oak, sumac soaps detergents cosmetics jewelry external feminine, 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

Spl product data elements

Usually a list of ingredients in a drug product.
Hydrocortisone with Aloe Hydrocortisone GLYCERYL MONO AND DIPALMITOSTEARATE EDETATE DISODIUM PROPYLPARABEN SORBITAN MONOSTEARATE PROPYLENE GLYCOL PETROLATUM ALOE BARBADENSIS LEAF EXTRACT CETYL ALCOHOL WATER HYDROCORTISONE HYDROCORTISONE METHYLPARABEN POLYSORBATE 60 MINERAL OIL

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.
Hydrocortisone Label Image

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.
Other Information store at controlled room temperature 20°-25°C (68°-77°F) Other Information Distributed By: Rugby Laboratories® Indianapolis, IN 46268 www.majorpharmaceuticals.com 1-800-616-2471 This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark Cortizone 10®

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, consult a doctor For the external genital itching if you have a vaginal discharge, 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 (1-800-222-1222) immediately.

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 using this product and ask a doctor if Conditions worsen symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by 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 avoid contact with the eyes. do not begin the use of any other hydrocortisone product unless you have consulted a doctor for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator.

How supplied

Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.
HOW SUPPLIED Product: 50090-7428 NDC: 50090-7428-0 28 g in a TUBE / 1 in a BOX

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 avoid contact with eyes do not put this product into the rectum by using fingers or any mechanical device or applicator For External Anal Itching Users: do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding, consult a doctor promptly children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton as it contains important information

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