NDC 46122-677 Gnp Hemorrhoidal

Mineral Oil, Petrolatum, Phenylephrine, Hcl

NDC Product Code 46122-677

NDC CODE: 46122-677

Proprietary Name: Gnp Hemorrhoidal 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: Mineral Oil, Petrolatum, Phenylephrine, Hcl 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.

  • Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

NDC Code Structure

  • 46122 - Amerisource Bergen

NDC 46122-677-46

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

NDC Product Information

Gnp Hemorrhoidal with NDC 46122-677 is a a human over the counter drug product labeled by Amerisource Bergen. The generic name of Gnp Hemorrhoidal is mineral oil, petrolatum, phenylephrine, hcl. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Amerisource Bergen

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.

Gnp 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.

  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
  • PETROLATUM 749 mg/g
  • MINERAL OIL 140 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.

  • THYME OIL (UNII: 2UK410MY6B)
  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ALCOHOL (UNII: 3K9958V90M)
  • LANOLIN (UNII: 7EV65EAW6H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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: Amerisource Bergen
Labeler Code: 46122
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: 01-26-2021 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 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.

Gnp Hemorrhoidal Product Label Images

Gnp 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

Otc - Active Ingredient

Active ingredients PurposesMineral oil 14.0%.....................................................Skin protectantPetrolatum 74.9%....................................................Skin protectantPhenylephrine HCI 0.25%.......................................Vasconstrictor

Otc - Purpose

  • Useshelps relieve the local itching and discomfort associated with hemorrhoidstemporarily shrinks hemorrhoidal tissue and relieves burningtemporarily provides a coating for relief of anorectal discomfortstemporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

WarningsFor external and/or intrarectal use only

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart diseasehigh blood pressurethyroid diseasedifficulty in urination due to enlargement of the prostate glanddiabetesAsk a doctor of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

Otc - When Using

  • When using this productdo not exceed the recommended daily dosage unless directed by a doctor

Otc - Stop Use

  • Stop use and ask a doctor ifrectal bleeding occurscondition worsens or does not improve within 7 daysintroduction of applicator into rectum causes addition pain

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

  • Directionsadults: 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, peel back foil sealapply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementintrarectal use: remove cover from applicator, attach applicator to tube, lubricant applicator well and gently insert applicator into the rectumthoroughly cleanse applicator after each use and replace coveralso apply ointment to external arearegular use provided continual therapy for relief of symptomschildren under 12 years of age: ask a doctor

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methyparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified water, white wax

Dosage & Administration

Distributed By:Amerisource BergenMade in China

* Please review the disclaimer below.