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| Product NDC Code | 73598-1014 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone |
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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 | ||||
| Application Number | M017 | ||||
| Labeler Name | JHK Inc dba American Safety & First Aid | ||||
| 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 acetate 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 Adults and children two years and over: apply to affected area not more than three to four times daily Children under two years: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin/Phenoxyethanol Glycerin, Glycerol fatty acid ester Mineral Oil, Petrolatum, 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.Use Temporarily relieves itching associated with minor skin irritations and rashes due to: Eczema Insect Bites Poison Ivy, Oak or Sumac Soaps, Detergents or Cosmetics Jewelry
Purpose
Information about the drug product’s indications for use.Purpose Anti-Itch Cream
Spl product data elements
Usually a list of ingredients in a drug product.HYDROCORTISONE HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE HYDROCORTISONE CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER PETROLATUM WATER
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.PRINCIPAL DISPLAY PANEL - 25 Packet Carton Product #1014 Hydrocortisone Cream USP 1% For the temporary relief of itching associated with minor skin irritations and rashes. 25 - Unit Dose Packets PRINCIPAL DISPLAY PANEL - 25 Packet Carton
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.Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use With any other hydrocortisone product unless you have consulted a doctor For the treatment of diaper rash, consult a doctor
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
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 Symptoms persist for more than seven days Symptoms clear up and occur again within a few days
Storage and handling
Information about safe storage and handling of the drug product.Other Information Do not use if packet is torn, cut or opened Store at room temperature (do not freeze) See packet for Lot Number and expiration date
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 With any other hydrocortisone product unless you have consulted a doctor For the treatment of diaper rash, consult a doctor Stop use and ask a doctor if Condition worsens Symptoms persist for more than seven days Symptoms clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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