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Product NDC Code | 0096-0732 | ||||
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Drug Name | Aquanil hc |
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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 | LOTION | ||||
RxCUI drug identifier | 103403, 1043063 |
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Application Number | M015 | ||||
Labeler Name | Person and Covey | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Hydrocortisone
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 -Shake will before using. -For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily. -For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a ddoctor. -Store away from excessive heat or cold.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Laureth Sulfate, Stearyl Alcohol, Simethicone, Xanthan Gum
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 minor skin irritations, inflamaations, itching and rashes caused by: -insect bites -eczema -psoriasis -soaps -detergents -cosmetics, -jewelry, -poison oak, -poison sumac -Other uses of this product should be undertaken only under the advice and supervision of a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Antipruritic (Anti-itch)
Spl product data elements
Usually a list of ingredients in a drug product.Aquanil HC Hydrocortisone HYDROCORTISONE HYDROCORTISONE BENZYL ALCOHOL WATER SODIUM LAURYL SULFATE XANTHAN GUM GLYCERIN CETYL ALCOHOL STEARYL ALCOHOL
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.Package Label. Principal Display Panel Aquanil HC
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 the Reach of Children Keep out of the reach of children. If swallowed, get medical help or contact 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.Questions? Questions? Please call (800) 423-2341
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.Stop Use and Ask a Doctor Stop use and ask a doctor if: -Condition worsens -If symptoms persit for more than 7 days or clear up and occur again within a few days. Discocntinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. -Do no use for diaper rash. Consult a doctor.
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 get into eyes. If contact occurs, rinse thoroughly with water.
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