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| Product NDC Code | 0536-1407 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone cream with aloe |
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| Type | Brand | ||||
| 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 | Rugby Laboratories | ||||
| Packages |
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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 Cream with Aloe Hydrocortisone GLYCERYL MONO AND DIPALMITOSTEARATE EDETATE DISODIUM PROPYLPARABEN SORBITAN MONOSTEARATE PROPYLENE GLYCOL PETROLATUM ALOE VERA LEAF 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.Package Label 371172 Rugby Hydrocortisone Cream with Aloe 112823 CDER
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.
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