NDC 0924-1132 Hydrocortisone

Hydrocortisone

NDC Product Code 0924-1132

NDC 0924-1132-02

Package Description: 12 PACKET in 1 CARTON > .9 g in 1 PACKET (0924-1132-01)

NDC 0924-1132-03

Package Description: 144 PACKET in 1 CARTON > .9 g in 1 PACKET (0924-1132-01)

NDC 0924-1132-04

Package Description: 25 PACKET in 1 CARTON > .9 g in 1 PACKET (0924-1132-01)

NDC Product Information

Hydrocortisone with NDC 0924-1132 is a a human over the counter drug product labeled by Acme United Corp. The generic name of Hydrocortisone is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Acme United Corp

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.

  • HYDROCORTISONE 10 mg/g

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)

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: Acme United Corp
Labeler Code: 0924
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: 11-06-2015 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: 12-31-2019 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 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. Values = ‘Y’ or ‘N’.

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Information for Patients

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]

* Please review the disclaimer below.

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

Other

Drug Facts

Active Ingredients

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation or rashes.
Other uses of product should be only under the advice of supervision of a doctor.

Warnings

For external use only

Do Not Use

  • In eyes
  • For treatment of dipper rash

Stop Use, Ask A Doctor

  • If condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • With use of other hydrocortisone products

Keep Out Of Reach Of Children.

If ingested, contact a Poison Control Center right away

Directions

  • Apply to affected area not more than 3 to 5 times daily
  • Children under 2: as a doctor

Inactive Ingredients

Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

* Please review the disclaimer below.