NDC 72189-276 Hydrocortisone

Hydrocortisone

NDC Product Code 72189-276

NDC 72189-276-28

Package Description: 28.4 g in 1 TUBE

NDC Product Information

Hydrocortisone with NDC 72189-276 is a a human over the counter drug product labeled by Direct Rx. The generic name of Hydrocortisone is hydrocortisone. The product's dosage form is cream and is administered via topical form.

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 What 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)

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


Inactive Ingredient(s)

About 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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CHLOROCRESOL (UNII: 36W53O7109)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • WATER (UNII: 059QF0KO0R)
  • CETETH-20 (UNII: I835H2IHHX)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)

Administration Route(s)

What 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

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct Rx
Labeler Code: 72189
FDA Application Number: part348 What 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. What 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: 09-21-2021 What 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: 12-31-2022 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.

Exclude Flag: N - NO 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".

* 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

Otc - Active Ingredient

Hydrocortisone 1%

Otc - Purpose

Antipruritic (Anti-itch)

Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.

Children under 2 years of age - Do not use. Consult a doctor.
For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.

Otc - When Using

Relieves itches and rashes due to:Eczema

Psoriasis

Seborrheic dermatitis

Poison ivy

Poison oak

Poison sumac

Insect bites

External anal itching

Soaps

Detergents

Cosmetics

Jewelry
Temporary relief of external anal and genital itching.Other use of the product should only be under the advice and supervision of a doctor.

Warnings

For external use onlyDo not use:In the eyes

For diaper rash

If you have vaginal discharge

More than the recommended dosage
Ask doctor before use:If you are pregnant or breast feedingStop use and ask a doctor if:Condition worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.​When using this product:Do not put this product into rectum by using fingers or any mechanical device or applicator.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Other Safety Information

Store between 20ºC and 25ºC (68ºFk and 77ºF)

avoid excessive heat and humidity

Inactive Ingredient

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

* Please review the disclaimer below.