NDC 52810-802 Hemorrhoid Relief

Calendula Officinalis Flower, Sambucus Nigra Flower, Echinacea Angustifolia, Thuja Occidentalis

NDC Product Code 52810-802

NDC CODE: 52810-802

Proprietary Name: Hemorrhoid 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: Calendula Officinalis Flower, Sambucus Nigra Flower, Echinacea Angustifolia, Thuja Occidentalis 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.

NDC Code Structure

  • 52810 - Puremedy

NDC 52810-802-11

Package Description: 30 mL in 1 JAR

NDC Product Information

Hemorrhoid Relief with NDC 52810-802 is a a human over the counter drug product labeled by Puremedy. The generic name of Hemorrhoid Relief is calendula officinalis flower, sambucus nigra flower, echinacea angustifolia, thuja occidentalis. The product's dosage form is salve and is administered via topical form.

Labeler Name: Puremedy

Dosage Form: Salve - A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).

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.

Hemorrhoid 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.

  • CALENDULA OFFICINALIS FLOWER 1 [hp_X]/100mL
  • SAMBUCUS NIGRA FLOWER 1 [hp_X]/100mL
  • ECHINACEA ANGUSTIFOLIA 1 [hp_X]/100mL
  • THUJA OCCIDENTALIS LEAF 1 [hp_X]/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.

  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CANADA BALSAM (UNII: K304VI98I3)

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: Puremedy
Labeler Code: 52810
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 10-18-2012 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.

Hemorrhoid Relief Product Label Images

Hemorrhoid 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

Otc - Active Ingredient

ACTIVE INGREDIENTSORG. CALENDULA OFFICINALIS (1X) HPUS) (MARIGOLD)ORG. SAMBUCUS NIGRA (1X) HPUS (ELDER BARK AND FLOWER)ORG. ECHINACEA ANGUSTIFOLIA (1X) HPUS (ECHINACEA)ORG. THUJA OCCIDENTALIS (1X) HPUS (ARBOR VITAE)

Otc - Purpose

PURPOSESKIN HEALING AGENTREMEDY FOR SWELLINGREMEDY FOR TOPICAL INFECTIONREMEDY FOR HEMORRHOIDS

Indications & Usage

USES: TO RELIEVE PAINFUL SYMPTOMS ASSOCIATED WITH HEMORRHOIDS

Dosage & Administration

DIRECTIONS: APPLY TOPICALLY 2-3 TIMES PER DAY TO CLEAN SKIN OR AS DIRECTED BY YOUR PHYSICIAN.

Inactive Ingredient

INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, PROPRIETARY BLEND OF PINE AND FIR EXTRACTS

Warnings

WARNINGS: DO NOT USE IF ALLERGIC TO OR SENSITIVE TO ANY INGREDIENT IN THIS SALVE. TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. IF CONDITION PERSISTS OR WORSENS AFTER 3 DAYS SEE A DOCTOR. AVOID DIRECT CONTACT WITH EYES. USE ONLY AS DIRECTED. KEEP ALL DRUGS OUT OF USE OF CHILDREN. SAFE TO USE FOR ALL AGES.

Otc - Keep Out Of Reach Of Children

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

Storage And Handling

STORE IN A COOL DRY PLACE OR REFRIGERATE.

Otc - Questions

CUSTOMER SERVICE 818-851-9014

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