NDC 43749-621 Avedana Hydrocortisone Cream With Aloe

Hydrocortisone

NDC Product Code 43749-621

NDC CODE: 43749-621

Proprietary Name: Avedana Hydrocortisone Cream With Aloe 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 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 a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 43749 - Unipack, Inc.
    • 43749-621 - Avedana Hydrocortisone Cream With Aloe

NDC 43749-621-01

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE (43749-621-03)

NDC Product Information

Avedana Hydrocortisone Cream With Aloe with NDC 43749-621 is a a human over the counter drug product labeled by Unipack, Inc.. The generic name of Avedana Hydrocortisone Cream With Aloe 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.

Avedana Hydrocortisone Cream With Aloe 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.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)

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: Unipack, Inc.
Labeler Code: 43749
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: 08-27-2021 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.

Avedana Hydrocortisone Cream With Aloe Product Label Images

Avedana Hydrocortisone Cream With Aloe 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

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

  • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:eczemainsect bitespoison ivypoison oakpoison sumacsoapsjewelrydetergentscosmeticspsoriasisseborrheic dermatitisfor external gential, feminine and anal itchingother uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • For external feminine itching if you have a vaginal discharge. Consult a doctor.for the treatment of diaper rash. Consult a doctor.

When Using This Product

  • Avoid contact with the eyesdo not begin the use of any other hydrocortisone product unless directed by a doctorfor external anal itchingdo not use more than directed unless directed by a doctordo not put this product into the rectum by using fingers or any mechanical device or applicator

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 to 4 times dailyChildren under 2 years of age *do not use, consult a doctorFor external anal itchingAdults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a solft cloth before application of this product.Children under 12 years of age: consult a doctor

Other Information

  • Storage temperature: not to exceed 30 °C (86 °F). Protect from freezing.Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

Aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.

Questions?

Call 724-733-7381

* Please review the disclaimer below.