NDC 61767-224 Hydrocortisone

Product Information

Hydrocortisone is product labeled by Blossom Pharmaceuticals. The product's dosage form is and is administered via form.

Product Code61767-224
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Hydrocortisone
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Blossom Pharmaceuticals
Labeler Code61767
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-01-2014
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2018
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Hydrocortisone?


Product Packages

NDC 61767-224-01

Package Description: 72 TUBE in 1 CASE > 28.3 g in 1 TUBE

NDC 61767-224-02

Package Description: 12 BOX in 1 CASE > 144 PACKET in 1 BOX > .9 g in 1 PACKET

NDC 61767-224-03

Package Description: 1728 PACKET in 1 CASE > .9 g in 1 PACKET

NDC 61767-224-04

Package Description: 12 JAR in 1 CASE > 425 g in 1 JAR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Hydrocortisone Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Hydrocortisone Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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Patient Education

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor s...
[Read More]

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Hydrocortisone Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)


Warnings:



For external use only


Purpose



For temporary relief of;

  • minor skin irritations
  • Itching and rashes due to;

    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • and for external itching of;

      • genital
      • feminine and
      • anal itching

Do Not Use:



  • in the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • in the rectum bu using fingers or any other mechanical device or applicator

Stop Use And Ask A Physician If:



  • the condition persists or gets worse
  • symptoms clear up and occur again within a few days
  • you are pregnant or breast feeding

Keep Out Of Reach Of Children



  • If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration:



Adults and children over 2 years of age
  • Apply evenly to affected area no more than 3 or 4 times daily.
  • Children under 2 years of age
    • Do not use
    • consult a physician
    • Adults
      • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
      • Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
      • apply externally to the area up to 6 times daily or after each bowel movement

Other Information:



  • Store at 20 deg - 25 deg C (68 deg - 77 deg F)
  • Avoid excessive heat and humidity

Inactive Ingredients:



Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Sodium Betabisulphite, White Soft Paraffin, Water (purified)


Indications & Usage



For temporary relief of minor skin irritations and external itching.


Principal Display Panel



Blossom Pharmaceuticals Hydrocortisone 1%

Hydrocortisone.jpg


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