NDC 44019-001 Medicated-pads Hemorrhoidal Pads With Witch Hazel

Witch Hazel

NDC Product Code 44019-001

NDC CODE: 44019-001

Proprietary Name: Medicated-pads Hemorrhoidal Pads With Witch Hazel 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: Witch Hazel 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

  • 44019 - Yinjing Medical Technology (shanghai) Co., Ltd.
    • 44019-001 - Medicated-pads Hemorrhoidal Pads With Witch Hazel

NDC 44019-001-00

Package Description: 1 PATCH in 1 PACKET > .36 g in 1 PATCH

NDC Product Information

Medicated-pads Hemorrhoidal Pads With Witch Hazel with NDC 44019-001 is a a human over the counter drug product labeled by Yinjing Medical Technology (shanghai) Co., Ltd.. The generic name of Medicated-pads Hemorrhoidal Pads With Witch Hazel is witch hazel. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Yinjing Medical Technology (shanghai) Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Medicated-pads Hemorrhoidal Pads With Witch Hazel 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.

  • WITCH HAZEL 50 g/100g

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: Yinjing Medical Technology (shanghai) Co., Ltd.
Labeler Code: 44019
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: 08-03-2016 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.

Medicated-pads Hemorrhoidal Pads With Witch Hazel Product Label Images

Medicated-pads Hemorrhoidal Pads With Witch Hazel 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 Ingredient

Witch Hazel,50% v/v

Purpose

Astringent

Use

For temporary relief of local discomfort itching, burning, and irritation associated with hermorrhoids.

Warnings

For external use only. Avoid contact with eyes.

Consult A Doctor

  • If condition worsens or does not improve within 7 days.In case of bleeding.Before exceeding the recommended dosage.Do not put this product into rectum using fingers or any mechanical device or applicator.

Directions

? As a hemorrhoidal treatment for adults and children 12 years of age and older.


? 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 soft cloth before each application of this product. Gently apply to the affected area by patting and then discard. Apply to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.

Other Information

Store at room temperature 15


0 - 30


0 C (59


0 - 86


0 F)

Inactive Ingredients:

Purified Water, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Diazolidinyl Urea, Methyl Paraben, Propyl Paraben, Sodium Citrate, Citric Acid, Disodium EDTA.

* Please review the disclaimer below.