NDC 0113-0944 Good Sense Hemorrhoidal Maximum Strength Pain Relief

Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum

NDC Product Code 0113-0944

NDC CODE: 0113-0944

Proprietary Name: Good Sense Hemorrhoidal Maximum Strength Pain Relief 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: Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 0113 - L. Perrigo Company

NDC 0113-0944-24

Package Description: 1 TUBE in 1 CARTON > 51 g in 1 TUBE

Price per Unit: $0.04637 per GM

NDC Product Information

Good Sense Hemorrhoidal Maximum Strength Pain Relief with NDC 0113-0944 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Hemorrhoidal Maximum Strength Pain Relief is glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1293649.

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.

Good Sense Hemorrhoidal Maximum Strength Pain Relief 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LAURETH-23 (UNII: N72LMW566G)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Glycerol - [CS]
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Non-Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

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

Labeler Name: L. Perrigo Company
Labeler Code: 0113
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: 02-28-2008 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.

Good Sense Hemorrhoidal Maximum Strength Pain Relief Product Label Images

Good Sense Hemorrhoidal Maximum Strength Pain Relief 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

Glycerin 14.4%Phenylephrine HCl 0.25%Pramoxine HCl 1%White petrolatum 15%

Purpose

ProtectantVasoconstrictorLocal anesthetic

Uses

  • •for temporary relief of pain, soreness and burning •helps relieve the local itching and discomfort associated with hemorrhoids •temporarily shrinks hemorrhoidal tissue •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 use only

Ask A Doctor Before Use If You Have

  • •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged 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 •do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • •bleeding occurs •condition worsens or does not improve within 7 days •an allergic reaction develops •the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

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.

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 cream. •when first opening the tube, puncture foil seal with top end of cap •apply externally or in the lower portion of the anal canal only •apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement •for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus. •thoroughly cleanse dispensing cap after each use and replace cover •children under 12 years of age: ask a doctor

Other Information

  • •store at 20°-25°C (68°-77°F)

Inactive Ingredients

Aloe barbadensis leaf extract, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, vitamin E, xanthan gum

* Please review the disclaimer below.