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| Product NDC Code | 61387-252 | ||||
|---|---|---|---|---|---|
| Drug Name | Truelipids 1% hydrocortisone barrier cream |
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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 | part348 | ||||
| Labeler Name | Claridei Laboratories | ||||
| 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.........Purpose Hydrocortisone 1% .....Anti-itch
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 for itching of skin irritation, inflammation and rashes: adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily children under 2 years of age: ask a doctor for external anal and genital itching adult: when practical clean the affected area with mild soap and water and rinse thoroughly gently dry by patting or blotting with toilet tissueor a soft cloth before applying
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Caprylic/capric Triglyceride, Petrolatum, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Polyglyceryl-2 Stearate, Isostearyl Isostearate, Cetyl Allcohol, Propanediol (from Corn) , Glycerin, Stearyl Alcohol, Euphorbia Cerifera (Candelilla Wax), C10-30 Cholesterol/Lanosterol Esters, Potassium Stearate, Glycyrrhetinic Acid(from Licorice root), Glyceryl Distearate, Stearic Acid, Caprylyl Glycol, Xanthan Gum, Niacinamide, 1,2-Hexanediol, Phytospingosine, Disodium EDTA, Ceramide NP, Tocopherol
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.Stop use and ask a doctor if condition worsens rectal bleeding occurs symptoms persist more than 7 days or clear up and occur again within a few days. do not begin use of any other hydrocortisone product unless you have asked a doctor
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents soaps cosmetics jewelry seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor
Spl product data elements
Usually a list of ingredients in a drug product.TrueLipids 1% Hydrocortisone Barrier Cream Hydrocortisone MEDIUM-CHAIN TRIGLYCERIDES TOCOPHEROL POLYGLYCERYL-2 STEARATE CANDELILLA WAX POTASSIUM STEARATE ENOXOLONE HYDROCORTISONE HYDROCORTISONE STEARIC ACID GLYCERYL MONOSTEARATE C10-30 CHOLESTEROL/LANOSTEROL ESTERS CAPRYLYL GLYCOL NIACINAMIDE PHYTOSPHINGOSINE EDETATE DISODIUM ANHYDROUS PETROLATUM GLYCERIN GLYCERYL DISTEARATE XANTHAN GUM 1,2-HEXANEDIOL CERAMIDE NP ISOSTEARYL ISOSTEARATE WATER NEOPENTYL GLYCOL DIHEPTANOATE STEARYL ALCOHOL CETYL ALCOHOL PROPANEDIOL
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.CLMD Sensitive Skin Care True Lipids 1% Hydrocortisone Barrier Cream Net Wt 1.7 fl oz (50g) hydrocortisone
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 20°-25ºC (68º-77ºF)
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 genital area if you have a vaginal discharge. consult a doctor for the treatment of diaper rash. consult a doctor when using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into rectim by using fingers or any mechanical device or applicator
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