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| Product NDC Code | 71399-0120 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone |
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| Type | Generic | ||||
| 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 | ||||
| Application Number | part348 | ||||
| Labeler Name | AKRON PHARMA INC | ||||
| 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 1% (Micronized)
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 doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, 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.Use For the temporary relief of minor skin irritations, inflammations, 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.Hydrocortisone Hydrocortisone WATER GLYCERIN CETYL ALCOHOL BENZYL ALCOHOL SODIUM LAURYL SULFATE STEARYL ALCOHOL ALOE VERA LEAF XANTHAN GUM 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.lotion
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 Rev. 03/19 Manufactured in U.S.A
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 Keep out of the reach of children. If swallowed, get medical help or contact 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 away from excessive heat or cold. Shake well before using.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Please Call 1(877) 225-6999
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 if Condition worsens If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue 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.
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 Do not get into eyes. If contact occurs, rinse thoroughly with water.
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