NDC 83311-335 Simple Promise Simple H Hemorrhoid Relief Cream
Phenylephrine Hydrochloride, Pramoxine Hydrochloride Cream Topical

Product Information

What is NDC 83311-335?

The NDC code 83311-335 is assigned by the FDA to the product Simple Promise Simple H Hemorrhoid Relief Cream which is a human over the counter drug product labeled by Simple Promise Pte Ltd. The generic name of Simple Promise Simple H Hemorrhoid Relief Cream is phenylephrine hydrochloride, pramoxine hydrochloride. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 83311-335-00 1 tube in 1 box / 56.7 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code83311-335
Proprietary Name 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.		Simple Promise Simple H Hemorrhoid Relief Cream
Non-Proprietary Name 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.		Phenylephrine Hydrochloride, Pramoxine Hydrochloride
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Phenylephrine Hydrochloride; Pramoxine Hydrochloride
Product Type 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.		Human Otc Drug
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.		Simple Promise Pte Ltd
Labeler Code83311
FDA Application Number 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.		part346
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-06-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Simple Promise Simple H Hemorrhoid Relief Cream?


Product Packages

NDC Code 83311-335-00

Package Description: 1 TUBE in 1 BOX / 56.7 g in 1 TUBE

Product Details

What are Simple Promise Simple H Hemorrhoid Relief Cream Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Simple Promise Simple H Hemorrhoid Relief Cream Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1293856 - phenylephrine HCl 0.25 % / pramoxine HCl 1 % Rectal Cream
  • RxCUI: 1293856 - phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
  • RxCUI: 1293856 - phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % Rectal Cream

Simple Promise Simple H Hemorrhoid Relief Cream Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Simple Promise Simple H Hemorrhoid Relief Cream Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Drug Facts




Active Ingredients



Phenylephrine HCl 0.25%

Pramoxine HCl 1%


Purpose



Vasoconstrictor

Local anesthetic


Uses



• for temporary relief of pain, soreness and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoid tissue
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful


Warnings



For external use only


Do Not Use



this product if you have

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor.


Ask A Doctor Or Pharmacist Before Use



if you are presently taking a prescription drug for high blood pressure or depression.


When Using This Product



• do not exceed the recommended daily dosage unless directed by a doctor.

• FOR INTRARECTAL USE: attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum.

In case of bleeding, consult a doctor promptly.


Stop Use And Ask A Doctor If



• condition worsens or does not improve within 7 days • an allergic reaction develops • the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions



• Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
• when first opening the tube, puncture foil seal with top end of cap
• apply externally or in the lower portion of the anal canal only
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement Children under 12 years of age: ask a doctor.


Other Information



• store at 20-25°C (68-77°F)
• do not use if printed safety seal on cap is broken or missing


Inactive Ingredients



Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Dimethicone, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel), Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.


Package Labeling: Simple Promise Simple H Hemorrhoid Relief Cream, 2Oz/56.7G



Label - Label

Label - Label


* Please review the disclaimer below.