NDC 71399-0110 Hemorrhoidal Hygiene Pads

Witch Hazel

NDC Product Code 71399-0110

NDC 71399-0110-1

Package Description: 175 mL in 1 JAR

NDC Product Information

Hemorrhoidal Hygiene Pads with NDC 71399-0110 is a a human over the counter drug product labeled by Akron Pharma Inc.. The generic name of Hemorrhoidal Hygiene Pads is witch hazel. The product's dosage form is solution and is administered via rectal form.

Labeler Name: Akron Pharma Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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 Hygiene 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 50 g/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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Akron Pharma Inc.
Labeler Code: 71399
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: 10-25-2019 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 Hygiene Pads Product Label Images

Hemorrhoidal Hygiene 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

Drug Facts

Witch Hazel 50%Purpose: Hemorrhoidal Astringent

Uses

For temporary relief of local discomfort,burning and irritation associated with Hemorrhoids

Warnings

  • For External Use OnlyAvoid contact with the eyesConsult a doctorIf condition worsens or does not improve within 7 daysIn case of bleedingBefore exceeding the recommended dosageDO NOT put this product into the rectum using fingers or any mechanical device.

Directions:

  • When practical, clean the affected area with mild soap and warm water, and rinse thoroughly

Dosage & Administration

  • Gently dry by patting or blotting with toilet tissue or a soft cloth before applyingApply externally to the affected area up to 6 times daily or after each bowel movement After application, discard pad Children under 12 years of age: consult a doctor

Other Information

  • Store at room temperature 15°-30°C (59°-86°F)If adverse effects call 1-877-225-6999

Other Ingredients

Alcohol, Citric Acid, Deionized Water, DMDM Hydantoin,Glycerin, Sodium Citrate.

* Please review the disclaimer below.