NDC 43749-470 Hemorrhoidal Cream Maximum Strength

Hemorrhoidal Cream

NDC Product Code 43749-470

NDC CODE: 43749-470

Proprietary Name: Hemorrhoidal Cream Maximum Strength 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: Hemorrhoidal Cream 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.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

NDC 43749-470-01

Package Description: 1 TUBE in 1 CARTON > 25.5 g in 1 TUBE (43749-470-03)

NDC 43749-470-02

Package Description: 1 TUBE in 1 CARTON > 51 g in 1 TUBE (43749-470-04)

NDC Product Information

Hemorrhoidal Cream Maximum Strength with NDC 43749-470 is a a human over the counter drug product labeled by Unipack. The generic name of Hemorrhoidal Cream Maximum Strength is hemorrhoidal cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Unipack

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.

Hemorrhoidal Cream Maximum Strength 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.

  • PETROLATUM 150 mg/g
  • GLYCERIN 144 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g
  • PHENYLEPHRINE HYDROCHLORIDE 25 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.

  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • ALOE (UNII: V5VD430YW9)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • LANOLIN (UNII: 7EV65EAW6H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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.
  • 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: Unipack
Labeler Code: 43749
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: 11-04-2020 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: 12-31-2021 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.

Hemorrhoidal Cream Maximum Strength 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 anastheticProtectant

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-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-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 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.  Lubrcate 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.

Apply externally or in the lower portion of the anal canal only. Apply 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. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

Other Information

Store at 20-25oC (68-77oF)

Inactive Ingredients

Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water

Avedana Hemorrhoidal Cream®Maximum Strength W/ Aloe & Vitamin Etube Label

Tube Label

Avedana Hemorrhoidal Cream®Maximum Strength W/ Aloe & Vitamin E1 Tube | Net Wt 0.9 Oz (26 G)

0.9oz Carton Label

Avedana Hemorrhoidal Cream®Maximum Strength W/ Aloe & Vitamin E1 Tube | Net Wt 1.8 Oz (51 G)

1.8oz Tube Label

1.8oz Carton Label

* Please review the disclaimer below.