NDC 68786-223 Hydrocortisone

Hydrocortisone

NDC Product Code 68786-223

NDC Product Information

Hydrocortisone with NDC 68786-223 is a a human over the counter drug product labeled by Sion Biotext Medical Ltd. The generic name of Hydrocortisone is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sion Biotext Medical Ltd

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Hydrocortisone Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROCORTISONE 1 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
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.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sion Biotext Medical Ltd
Labeler Code: 68786
FDA Application Number: part348 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-31-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hydrocortisone Product Label Images

Hydrocortisone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Gram)

Hydrocortisone 1%

Purpose

Antipruritic (Anti-Itch)

Uses:

  • For temporary relief of itching associated withminor skin irritationsinflammationand rashes due toeczemainsect bitespoison ivypoison oakpoison sumardetergentscosmeticsjewelryseborrheic dermatitispsoriasisand for external genital, feminine and anal itching

Warnings:

FOR EXTERNAL USE ONLY​If pregnant or breastfeeding, ask a health professional before use.

Do Not Use

  • In the eyesfor diaper rashfor external genital or feminine itching if you have a vaginal dischargemore than the recommended daily dosage unless directed by a doctorthis product in the rectum by using fingers or any other mechanical device or applicator

Stop Use And Ask A Doctor If

  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not use this or any other hydrocortisone product in case of bleeding when used for anal itching

Keep Out Of Reach Of Children

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

Directions:

  • Adults and children 2 years of age and older:Apply to affected area not more than 3 or 4 times daily.children under 2 years of age:Consult a doctorWhen used for anal itching, cleanse the affected area with mild soap and warm waterand risne thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applyingchildren under 12:​Consult a doctor before using for anal itching

Other Information:

  • Store at 15o - 30oC (59o - 86oF)avoid excessive heat and humidity

Inactive Ingredients:

Cetostearyl Alcohol,Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

Distributed By

​SIONBRANDS, INC. ​754 Roble Rd, Suite 180, Allentown, PA, 18109, USA.

* Please review the disclaimer below.

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