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| Product NDC Code | 47832-205 | ||||||||
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| Drug Name | Hydrocortisone acetate |
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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 | 1043690 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | Bentlin Products LLC | ||||||||
| 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 acetate USP 1.0% w/w
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 the affected area not more than 3 to 4 times daily. Children under 2 years of age Do not use. Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients caprylic/capric triglyceride, caprytyl glycol, ceteareth-20, chamomillia recutitia flower extract, citric acid, glycerin, glyceryl, stearate, palmitic acid. petrolatum phenoxyethanol, stearic acid, purified water
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 irritation, inflammation and rashes due to: Atopic eczema Contact dermatitis from soaps, detergents or cosmetics Seborrheic dermatitis Psoriasis 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 Acetate Hydrocortisone Acetate HYDROCORTISONE ACETATE HYDROCORTISONE GLYCERIN WATER PETROLATUM MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL STEARATE SE PALMITIC ACID POLYOXYL 20 CETOSTEARYL ETHER CHAMOMILE ANHYDROUS CITRIC ACID PHENOXYETHANOL
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 - 2 oz Carton Label NDC 47832-205-34 exederm ® flare control cream for eczema & dermatitis NET WT 2 OZ (56g) 1% Hydrocortisone Anti-Itch Cream Principal Display Panel - 2 oz Carton Label
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 between 20°-25°C (68°-77°F)
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 On children under the age of 2 except under the supervision of 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? Call 908 630 9445 weekdays 9:00am to 4:30pm EST or visit us online at www.exederm.com
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 Symptoms persist for more than 7 days or clear up and occur again within a few days
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 use any other hydrocortisone product unless directed by a doctor
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 On children under the age of 2 except under the supervision of a doctor When using this product Avoid contact with the eyes Do not begin use any other hydrocortisone product unless directed by a doctor Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days 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