NDC 70942-135 Dr. Butler Hemorrhoid Treatment

Phenylephrine Hydrochloride 0.25%, Witch Hazel 50%

NDC Product Code 70942-135

NDC CODE: 70942-135

Proprietary Name: Dr. Butler Hemorrhoid Treatment 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: Phenylephrine Hydrochloride 0.25%, Witch Hazel 50% 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

  • 70942 - Beyond Health P.a.

NDC 70942-135-03

Package Description: 1 CAN in 1 CARTON > 85 g in 1 CAN

NDC Product Information

Dr. Butler Hemorrhoid Treatment with NDC 70942-135 is a a human over the counter drug product labeled by Beyond Health P.a.. The generic name of Dr. Butler Hemorrhoid Treatment is phenylephrine hydrochloride 0.25%, witch hazel 50%. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1599785.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Dr. Butler Hemorrhoid Treatment 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.


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.

  • SULISOBENZONE (UNII: 1W6L629B4K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALOE (UNII: V5VD430YW9)
  • ALCOHOL (UNII: 3K9958V90M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • 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.

  • 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: Beyond Health P.a.
Labeler Code: 70942
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: 12-10-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dr. Butler Hemorrhoid Treatment 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

Phenylephrine HCl 0.25%, Witch Hazel 50%

Otc - Purpose

Vasoconstrictor, Astringent

Indications & Usage

Temporarily reduces swelling associated with hemorrhoidal tissue. Temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders.

Warnings

For external use only.When using this product avoid spraying in eyes, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.
Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if bleeding
occurs, the condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, needed for longer than 1 week.

Otc - Pregnancy Or Breast Feeding

Ask a healthcare or professional before use.

Otc - Keep Out Of Reach Of Children

If swallowed, seek medical help or contact a Poison Control Center right away.

Dosage & Administration

Adults: when practical, cleanse the affected area with mild soap and warm water and pat dry. Spray the rectal area until thoroughly moist. Wipe off excess with a tissue, gently dry by patting or blotting with a tissue or a soft cloth, apply to the affected area up to 4 times daily especially at night in the morning or after each bowel movement. For children under 12 years of age, consult a doctor.

Inactive Ingredient

Alcohol, Aloe Barbadensis Leaf Extract, Benzophenone-4, Benzyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Hydroxyethylcellulose, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium Citrate, Tocopherol, Tocopheryl Acetate, Water.

* Please review the disclaimer below.