NDC 70000-0425 Hemorrhoidal Cream

Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, White Petrolatum

NDC Product Code 70000-0425

NDC Code: 70000-0425

Proprietary Name: Hemorrhoidal Cream 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 Hydrochloride, Pramoxine Hydrochloride, 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.


Code Structure
  • 70000 - Cardinal Health, Inc.
    • 70000-0425 - Hemorrhoidal Cream

NDC 70000-0425-1

Package Description: 1 TUBE in 1 BOX > 28 g in 1 TUBE

NDC Product Information

Hemorrhoidal Cream with NDC 70000-0425 is a a human over the counter drug product labeled by Cardinal Health, Inc.. The generic name of Hemorrhoidal Cream is glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cardinal Health, Inc.

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 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.

  • PRAMOXINE HYDROCHLORIDE .28 g/28g
  • GLYCERIN 4.032 g/28g
  • PHENYLEPHRINE HYDROCHLORIDE .07 g/28g
  • PETROLATUM 4.2 g/28g

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Cardinal Health, Inc.
Labeler Code: 70000
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: 04-03-2019 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.

Hemorrhoidal Cream Product Label Images

Hemorrhoidal Cream 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 anestheticProtectant

Uses

  • For temporary relief of pain, soreness and burninghelps relieve the local itching and discomfort associated with hemorrhoidstemporarily provides a coating for relief of anorectal discomfortstemporarily protects the inflamed irritated anorectal surface to help make bowel movements less painfultemporarily shrinks hemorrhoidal tissue

Warnings

For external use only.

When Using This Product

  • Do not put this product into the rectum by using fingers or any mechanical device or applicatordo not exceed recommended daily dosage unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurethyroid diseasediabetesdifficulty 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.

Stop Use And Ask A Doctor If

  • Bleeding occurscondition worsens or does not improve within 7 daysthe symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. Some people can develop allergic reactions to ingredients in this product.

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 (1-800-222-1222) right away.

Directions

  • Adults:when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.apply externally or in the lower portion of the anal canal only.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.Children under 12 years of age: consult a doctor.

Other Information

Store at room temperature 68° - 77° F (20° - 25° C).

Inactive Ingredients

Aloe barbadensis leaf extract, carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

* Please review the disclaimer below.

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