NDC 47682-923 Medi-first 1% Hydrocortisone

Hydrocortisone Acetate

NDC Product Code 47682-923

NDC CODE: 47682-923

Proprietary Name: Medi-first 1% Hydrocortisone 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.

Non-Proprietary Name: Hydrocortisone Acetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat hemorrhoids and itching/swelling in the rectum and anus. It is also used with other medications to treat certain intestinal problems (such as ulcerative colitis of the rectum and other rectal/anal inflammatory conditions). Hydrocortisone suppositories help to relieve rectal pain, itching, bloody diarrhea, and bleeding by reducing swelling (inflammation) directly in the rectum and anus. Hydrocortisone belongs to a class of drugs called corticosteroids.

NDC Code Structure

  • 47682 - Unifirst First Aid Corporation

NDC 47682-923-73

Package Description: 25 PACKET in 1 BOX > .9 g in 1 PACKET

NDC Product Information

Medi-first 1% Hydrocortisone with NDC 47682-923 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medi-first 1% Hydrocortisone is hydrocortisone acetate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Unifirst First Aid Corporation

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.

Medi-first 1% 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 ACETATE 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 06-01-2021 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.

Medi-first 1% Hydrocortisone Product Label Images

Medi-first 1% 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

Otc - Active Ingredient

Active ingredientHydrocortisone acetate (equivalent to Hydrocorisone 1%)

Otc - Purpose

PurposeAnti-itch cream

Indications & Usage

  • Usesfor the temporary relief of itching associated with minor skin irritations and rashesother uses of this product should be only under the advice and supervision of a doctor

Warnings

WarningsFor external use only.

Otc - Do Not Use

Do not use for the treatment of diaper rash. Consult a doctor.

Otc - When Using

  • When using this productavoid contact with eyesdo not begin use of any other hydrocortisone product unless you've consulted a doctor

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayscondition clears up and occurs again within a few days

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsadults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times dailychildren under 2 years of age: do not use, consult a doctor

Other Safety Information

  • Other informationclean the affected areastore at room temperature (do not freeze)tamper evident. Do not use any opened or torn packetsyou may reportr a serioud adverse reaction to this product to 800-634-7680

Inactive Ingredient

Inactive ingredientscetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

Otc - Questions

Questions or comments? 1-800-634-7680

* Please review the disclaimer below.