NDC 73239-1901 Hemorrhoidal Relief Cream

Lidocaine, Zinc Oxide Cream

NDC Product Code 73239-1901

NDC CODE: 73239-1901

Proprietary Name: Hemorrhoidal Relief 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: Lidocaine, Zinc Oxide 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 medication is used to relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

NDC Code Structure

  • 73239 - Kanamed Inc.

NDC 73239-1901-1

Package Description: 50 mL in 1 TUBE

NDC Product Information

Hemorrhoidal Relief Cream with NDC 73239-1901 is a a human over the counter drug product labeled by Kanamed Inc.. The generic name of Hemorrhoidal Relief Cream is lidocaine, zinc oxide cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Kanamed 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 Relief 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.

  • LIDOCAINE 4 mg/100mL
  • ZINC OXIDE 1 mg/100mL

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 WHOLE (UNII: KIZ4X2EHYX)
  • HEMP (UNII: TD1MUT01Q7)

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: Kanamed Inc.
Labeler Code: 73239
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-16-2019 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 Relief Cream Product Label Images

Hemorrhoidal Relief 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

Otc - Active Ingredient

Lidocaine 4%Zinc Oxide 1%

Indications & Usage

For temporary relief of anorectal discomfort, itching pain, and soreness associated with hemorrhoids, anorectal disorders or inflamed hemorrhoidal tissue.​

Inactive Ingredient

  • Hemp seed oilAlovera JuiceCalendula OilBhringraja OilPhenylephrine HydrochlorideCarbopol 940CetostearylCetomacrogol 1000Silicon Oil 350GlycerinePropyl GlycolTriethanalaminePhenoxyethanolEthylhexlglycerinDM Water

Dosage & Administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad. 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 6 times daily.

Children under 12 years of age: consult a doctor.

Warnings

If condition worsens or does not improve within 7 days, consult a doctor.

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

In case of bleeding, consult a doctor promptly.

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

For temporary relief of anorectal discomfort, itching pain, and soreness associated with hemorrhoids, anorectal disorders or inflamed hemorrhoidal tissue.​​

* Please review the disclaimer below.