NDC 0904-6726 Major Prep Hemorrhoidal

Mineral Oil, Petrolatum, Phenylephrine Hcl

NDC Product Code 0904-6726

NDC 0904-6726-02

Package Description: 1 TUBE in 1 CARTON > 57 g in 1 TUBE

NDC Product Information

Major Prep Hemorrhoidal with NDC 0904-6726 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Major Prep Hemorrhoidal is mineral oil, petrolatum, phenylephrine hcl. The product's dosage form is ointment and is administered via rectal form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Major Prep Hemorrhoidal 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.

  • MINERAL OIL 14 g/100g
  • PETROLATUM 74.9 g/100g
  • PHENYLEPHRINE HYDROCHLORIDE .25 g/100g

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)
  • WATER (UNII: 059QF0KO0R)
  • THYME OIL (UNII: 2UK410MY6B)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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.

  • Rectal - Administration to the rectum.

Product Labeler Information

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

Labeler Name: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-06-2018 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.

Major Prep Hemorrhoidal Product Label Images

Major Prep Hemorrhoidal 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 Ingredients

Mineral oil 14%Petrolatum 74.9%Phenylephrine HCl 0.25%

Purposes

ProtectantVasoconstrictor

Uses

  • •helps relieve the local itching and discomfort associated with hemorrhoids •temporarily shrinks hemorrhoidal tissue and relieves burning •temporarily provides a coating for relief of anorectal discomforts •temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external and/or intrarectal use only

Ask A Doctor Before Use If You Have

  • •heart disease •high blood pressure •thyroid disease •diabetes •difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

Presently taking a prescription drug for high blood pressure or depression.

When Using This Product

Do not exceed the recommended daily dosage unless directed by a doctor

Stop Use And Ask A Doctor If

  • •bleeding occurs •condition worsens or does not improve within 7 days •introduction of applicator into the rectum causes additional pain

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • •adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. •when first opening the tube, puncture foil seal with top end of cap •apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement •intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover •also apply ointment to external area •regular use provides continual therapy for relief of symptoms •children under 12 years of age: ask a doctor

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients

Benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax

* Please review the disclaimer below.