NDC 57520-0778 Hemorrhoid Care

Hamamelis Virginiana, Aesculus Hippocastanum, Aloe Socotrina, Paeonia Officinalis, Ignatia Amara, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphorus, Podophyllum Peltatum, Pulsatilla, Sulphu

NDC Product Code 57520-0778

NDC Code: 57520-0778

Proprietary Name: Hemorrhoid Care 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: Hamamelis Virginiana, Aesculus Hippocastanum, Aloe Socotrina, Paeonia Officinalis, Ignatia Amara, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphorus, Podophyllum Peltatum, Pulsatilla, Sulphu 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

  • 57520 - Apotheca Company
    • 57520-0778 - Hemorrhoid Care

NDC 57520-0778-1

Package Description: 56.7 g in 1 TUBE

NDC Product Information

Hemorrhoid Care with NDC 57520-0778 is a a human over the counter drug product labeled by Apotheca Company. The generic name of Hemorrhoid Care is hamamelis virginiana, aesculus hippocastanum, aloe socotrina, paeonia officinalis, ignatia amara, lycopodium clavatum, nitricum acidum, nux vomica, phosphorus, podophyllum peltatum, pulsatilla, sulphu. The product's dosage form is gel and is administered via topical form.

Labeler Name: Apotheca Company

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Care 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.

  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/g
  • HORSE CHESTNUT 1 [hp_X]/g
  • ALOE 6 [hp_X]/g
  • PAEONIA OFFICINALIS ROOT 6 [hp_X]/g
  • STRYCHNOS IGNATII SEED 12 [hp_X]/g
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/g
  • NITRIC ACID 12 [hp_X]/g
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/g
  • PHOSPHORUS 12 [hp_X]/g
  • PODOPHYLLUM 12 [hp_X]/g
  • PULSATILLA VULGARIS 12 [hp_X]/g
  • SULFUR 12 [hp_X]/g
  • KRAMERIA LAPPACEA ROOT 12 [hp_X]/g
  • CHELIDONIUM MAJUS 30 [hp_C]/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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)

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: Apotheca Company
Labeler Code: 57520
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: 11-08-2011 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: 12-31-2018 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: E 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 Care Product Label Images

Hemorrhoid Care 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 INGREDIENTS:  Hamamelis virginiana 1X, Aesculus hippocastanum 1X, 30C, Aloe socotrina 6X, Paeonia officinalis 6X, Ignatia amara 12X, Lycopodium clavatum 12X, Nitricum acidum 12X, Nux vomica 12X, Phosphorus 12X, Podophyllum peltatum 12X, Pulsatilla 12X, Sulphur 12X, Ratanhia 12X, 30X,  Chelidonium majus 30C.

Otc - Purpose

INDICATIONS:  For temporary relief of itching and discomfort associated with hemorrhoids.

Warnings

WARNINGS:  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.Do not use if tamper evident seal is broken or missing.Store in a cool, dry placeFor topical use only.

Dosage & Administration

DIRECTIONS:  Apply a small amount externally to the affected area up to 6 times daily or after each bowel movement.  Children under 12 years of age: Consult a doctor.

Inactive Ingredient

INACTIVE INGREDIENTS:  Citric acid, Ethanol, Glycerin, Hydroxyethylcellulose, Purified water, Sodium benzoate.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.  If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

INDICATIONS:  For temporary relief of itching and discomfort associated with hemorrhoids.

Otc - Questions

Dist. By:MedCare GroupBoothwyn, PA 19060302-260-3111www.medcaregroups.com

* Please review the disclaimer below.

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