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| Product NDC Code | 55621-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Thera plus |
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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 | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ||||
| 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 for itching of skin irritation, inflammation and rashes: -adults and children 2 years of age and older: apply to the affected areanot more than 3 to 4 times dailt -for children udner 2 years of age: ask a doctor for external anal and genital itching, adults: -clean the affected area with mild soap and warm water and rinse clean. -dry the affected area before applying -apply to the affected area not mroe than 3 to 4 times daily -children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water Inactive Ingredients
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.- for temporary relief of itching associated with minor skin irritations,inflammation and rashes due to: Uses - eczema -insect bites -poison ivy -poison oak -poison sumac -soaps -jewelry -detergents -cosmetics -psoriasis -seborrheic dermatisis -for external genital, feminine 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.Thera Plus Hydrocortisone ALOE VERA LEAF GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL PETROLATUM PROPYLPARABEN SODIUM LAURYL SULFATE STEARYL ALCOHOL WATER HYDROCORTISONE HYDROCORTISONE
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.copy of label
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.. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children
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.Do not use -in genital area if you have a vaginal discharge. Consult a doctor -for the treatment of diaper rash. Consult a doctor Stop use and ask a doctor if -symptoms last for more than 7 days -the condition gets worse -symptoms clear up and then occur again within a few days -rectal bleeding occurs
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 eyes -do not use more than directed unless directed by a doctor -do not put this product into the rectum by using fingers or any other 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
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