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| Product NDC Code | 55621-018 | ||||
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| Drug Name | Assured |
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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 Pharmaceutic Al 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 ingredients 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 relieving of skin irritation, inflammation, and rashes •adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily •children under 2 years of age: ask a doctor • s: for external anal and genital itching, adult •when practical, clean the affected area with mild soap and warm water and rinse thoroughly •gently dry by patting or blotting with toilet tissue or soft cloth before applying •apply to affected area not more 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 juice, cetyl alcohol, Inactive ingredients dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate, isohexadecane, maltodextrin, methyl gluceth-20, methyparaben, petrolatum, phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic acid, tocopherol, water, zingiber officinale (ginger) root extract
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 •temporarily relieves itching ssociated with minor skin irritation, inflammation and rashesdue to: •eczema •psoriasis •poison ivy, oak, sumac •insect bites •detergents •jewelry •cosmetics •soaps •seborrheic dermatitis •temporarily relieves external anal and genital itching •other uses of this product should be under 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.Assured HYDROCORTISONE ALOE VERA LEAF CETYL ALCOHOL DIMETHICONE EDETIC ACID ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE ISOHEXADECANE MALTODEXTRIN METHYL GLUCETH-20 METHYLPARABEN PETROLATUM PHENOXYETHANOL POLYSORBATE 80 PROPYLENE GLYCOL SODIUM CITRATE STEARIC ACID TOCOPHEROL WATER GINGER 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.. If swallowed, get medical Keep out of reach of children help or contract 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.1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?
Storage and handling
Information about safe storage and handling of the drug product.Other information •store at room temperature 68° - 77° F (20° - 25° C)
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 •in the genital area if you have a vaginal Do not use 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 rectum by using fingers or any mechanical device or applicator. 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor. •rectal 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