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| Product NDC Code | 49314-0005 | ||||
|---|---|---|---|---|---|
| Drug Name | Unishield 1% |
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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 | Unishield | ||||
| 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 For adults and children 2 years of age and older: apply to affected area 3 to 4 times daily children under 12 years of age: for external anal itching, consult a doctor children under 2 years of age: do not use, consult a doctor adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolactum, phenoxyethanol, 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 temorary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, posison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes 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.Unishield 1% HYDROCORTISONE WATER GLYCERIN POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN MINERAL OIL PETROLATUM PHENOXYETHANOL 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.image description
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature (do not freeze) Tamper evident, do not use any opened or torn packets
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 in eyes for feminine itching When using this product: Keep out of eyes, ears, and mouth In case of contact with eyes, rinse eyes throughly with water Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears and occurs again within a few days you begin use of other hydrocortisone product unless you have consulted a doctor bleeding occurs
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