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| Product NDC Code | 51326-108 | ||||
|---|---|---|---|---|---|
| Drug Name | Aloe cort |
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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 | Topiderm, Inc. | ||||
| 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 USP 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, or as directed. Consult a physician for children under 2 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Imidazolidinyl Urea, Methylparaben, PPG-2 Myristyl Ether Propionate, Polysorbate-60, Propylparaben, Purified Water, Squalane, Triethanolamine.
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 from minor skin irritations, and rashes Other uses of this product should be only under the supervision of a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Antipruritic cream
Spl product data elements
Usually a list of ingredients in a drug product.Aloe Cort Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE YELLOW WAX BENZYL ALCOHOL CETOSTEARYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN IMIDUREA METHYLPARABEN PPG-2 MYRISTYL ETHER PROPIONATE POLYSORBATE 60 PROPYLPARABEN WATER SQUALANE TROLAMINE DIMETHICONE
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 - 57 g Tube Label DERMA TOPIX aloe cort cream Hydrocortisone USP, 1% Net wt. 2 oz. (57g) Topix Pharmaceuticals, Inc. • N. Amityville, NY 11701 DERMA TOPIX PRINCIPAL DISPLAY PANEL - 57 g Tube 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
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, seek professional assistance or contact a Poison Control Center immediately.
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 the eyes. If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, stop use of this product and consult a physician Do not use for treatment of diaper rash Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
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