NDC 73014-3050 Ancalima Hydrocortisone Cream

Hydrocortisone

NDC Product Code 73014-3050

NDC 73014-3050-2

Package Description: .9 g in 1 PACKET

NDC 73014-3050-3

Package Description: 28.3 g in 1 TUBE

NDC Product Information

Ancalima Hydrocortisone Cream with NDC 73014-3050 is a a human over the counter drug product labeled by Ancalima Lifesciences Limited. The generic name of Ancalima Hydrocortisone Cream is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Ancalima Lifesciences Limited

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.


Ancalima Hydrocortisone Cream 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.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CHLOROCRESOL (UNII: 36W53O7109)
  • CETETH-20 (UNII: I835H2IHHX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Ancalima Lifesciences Limited
Labeler Code: 73014
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: 04-08-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Ancalima Hydrocortisone Cream Product Label Images

Ancalima Hydrocortisone Cream 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 Acetate USP (1% w/w)

Purpose

Anti-itch

Uses

■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

Ask A Doctor Before Use

■ if you are pregnant or breast feeding

Stop Use And Ask A Doctor If

■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin 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

Directions

■ adults and children over 2 years of age■ apply evenly to affected area no more than 3 to 4 times daily■ children under 2 years of age■ do not use, consult a doctor ■ adults and children over 2 years of age■ apply evenly to affected area no more than 3 to 4 times daily■ children under 2 years of age■ do not use, consult a doctor■
Adults■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying■ apply externally to the area up to 6 times a daily or after a bowel movement■ after application discard pad■ do not flush in toilet

Other Information

■ store at 20-25C (68-77F) ■ avoid excessive heat and humidity

Inactive Ingredients

Cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, White white soft paraffin

* Please review the disclaimer below.

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