NDC 49035-465 Maximum Strength Hemorrhoidal Pads

Witch Hazel

NDC Product Code 49035-465

NDC 49035-465-10

Package Description: 100 CLOTH in 1 JAR

NDC 49035-465-20

Package Description: 200 CLOTH in 1 JAR

NDC Product Information

Maximum Strength Hemorrhoidal Pads with NDC 49035-465 is a a human over the counter drug product labeled by Walmart, Inc.. The generic name of Maximum Strength Hemorrhoidal Pads is witch hazel. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Walmart, Inc.

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.

Maximum Strength 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)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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: Walmart, Inc.
Labeler Code: 49035
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: 05-10-2019 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.

Maximum Strength Hemorrhoidal Pads Product Label Images

Maximum Strength 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

Hemorrhoidal Astringent

Uses

  • Temporarily relieves these external symptoms associated with hemorrhoids:itchingburningirritation

Warnings

For external use only.

When Using This Product

  • Do not exceed the recommended daily dosage unless directed by a doctordo not insert into rectum or vagina using fingers or any mechanical device.

Stop Use And Ask A Doctor If

  • Rectal 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

  • As hemorrhoidal treatment for adults:when practial cleanse the affected area with mild soap and warm water, and rinse thoroughlygently dry by patting or blotting with toilet tissue or soft cloth before applying.gently apply to the affected area by patting and then discardcan be used up to six times daily or after each bowel movementchildren under 12 years of age: consult a doctor

Other Information

  • Store at controlled room temperature 150- 30oC (590 - 86oF)

Inactive Ingredients

Water, Sodium Citrate, Citric Acid, Glycerin, Phenoxyethanol, Potassium Sorbate.

* Please review the disclaimer below.