NDC 52000-028 Hemorrhoid Anesthetic

NDC Product Code 52000-028

NDC CODE: 52000-028

Proprietary Name: Hemorrhoid Anesthetic 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.

NDC Code Structure

  • 52000 - Universal Distribution Center Llc

NDC 52000-028-37

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE (52000-028-39)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Hemorrhoid Anesthetic with NDC 52000-028 is a product labeled by Universal Distribution Center Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1372298.

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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • CORN OIL (UNII: 8470G57WFM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SHARK LIVER OIL (UNII: 4B24275HEU)
  • THYME OIL (UNII: 2UK410MY6B)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Universal Distribution Center Llc
Labeler Code: 52000
Start Marketing Date: 08-05-2016 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Hemorrhoid Anesthetic Product Label Images

Hemorrhoid Anesthetic 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

Active IngredientsMineral Oil 14%Petrolatum 74.9%Phenylephrine HCL 0.25%

Otc - Purpose

PurposeProtectantProtectantVasoconstrictor

Indications & Usage

  • UsesFor the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.

Warnings

WarningsFor external use only

Otc - Stop Use

  • Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days.
  • Do not exceed the recommended daily dosage unless directed by a doctor.In case of bleeding, consult a doctor promptly.Certain persons can develop allergic reactions to ingredients in this product.If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.If you are pregnant, do not use this product without first consulting a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If ingested seek medical attention immediately or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsCleanse the affected area with mild soap and warm water, rinse thoroughly.Dry by patting or blotting with toilet tissue or soft cloth before applying this product.Cover the entire affected area with a thin layer 1 to 3 times daily.Children under 12 years of age need to consult a doctor before using this product.

Other

  • Other InformationStore at room temperature 20ºC to 25ºC (68ºF to 77ºF)Lot No. & Exp. Date: see crimp of tube.

Inactive Ingredient

Inactive IngredientsPurified water, benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax.

* Please review the disclaimer below.