NDC 70000-0364 Medicated Hemorrhoidal Pads

Witch Hazel

NDC Product Code 70000-0364

NDC Code: 70000-0364

Proprietary Name: Medicated Hemorrhoidal Pads 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

  • 70000 - Cardinal Health
    • 70000-0364 - Medicated Hemorrhoidal Pads

NDC 70000-0364-1

Package Description: 1 JAR in 1 CARTON > 100 CLOTH in 1 JAR

NDC Product Information

Medicated Hemorrhoidal Pads with NDC 70000-0364 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Medicated Hemorrhoidal Pads is witch hazel. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Cardinal Health

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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 Hemorrhoidal Pads 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 500 mg/1

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALOE (UNII: V5VD430YW9)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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
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: 02-13-2019 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.

Medicated Hemorrhoidal Pads Product Label Images

Medicated Hemorrhoidal Pads 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%

Purpose

Astringent

Uses

  • Provides temporary relief of local itching and discomfort associated with hemorrhoidstemporary relief of irritation and burning.aids in protecting irritated anorectal areas.

Warnings

For external use only.

When Using This Product

  • Do not use more than directed unless told to do so by a doctordo not put directly in the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If

  • Bleeding occurscondition worsens or does not improve within 7 days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center right away. (1-800-222-1222).

Directions

  • Adults: cleane the affected area with mild soap and warm water, and rinse thoroughlygently dry by patting or blotting with toilet tissue prior to applying.apply externally to the affected area up to 6 times daily or after each bowel movementdispose of pad in thrash after use and wash hands, do not flushchildren under 12 years of age: consult a doctor

Other Information

  • Store at room temperature 15- 30oC (59 - 86oF)for use as a moist compress - if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use.

Inactive Ingredients

Water, Alcohol, Glycerin, Phenoxyethanol, Aloe, Decyl Glucoside, Potassium
Sorbate, Propylene Glycol, Sodium Benzoate, Citric Acid.

* Please review the disclaimer below.

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