NDC 71831-005 No More Products
Glycerin, Kaolin, Calamine, Menthol Cream Topical

Product Information

What is NDC 71831-005?

The NDC code 71831-005 is assigned by the FDA to the product No More Products which is a human over the counter drug product labeled by Pranicura Group Llc. The generic name of No More Products is glycerin, kaolin, calamine, menthol. The product's dosage form is cream and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 71831-005-01 1 tube in 1 box / 35 g in 1 tube, 71831-005-02 1 tube in 1 box / 35 g in 1 tube, 71831-005-03 1 tube in 1 box / 35 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 Code71831-005
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.		No More Products
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.		Glycerin, Kaolin, Calamine, Menthol
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.		Glycerin; Kaolin; Menthol; Zinc Oxide
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.		Pranicura Group Llc
Labeler Code71831
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.		03-01-2023
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 No More Products?


Product Packages

NDC Code 71831-005-01

Package Description: 1 TUBE in 1 BOX / 35 g in 1 TUBE

NDC Code 71831-005-02

Package Description: 1 TUBE in 1 BOX / 35 g in 1 TUBE

NDC Code 71831-005-03

Package Description: 1 TUBE in 1 BOX / 35 g in 1 TUBE

Product Details

What are No More Products 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.
  • GLYCERIN 25 g/100g
  • KAOLIN 12.5 g/100g - The most common mineral of a group of hydrated aluminum silicates, approximately H2Al2Si2O8-H2O. It is prepared for pharmaceutical and medicinal purposes by levigating with water to remove sand, etc. (From Merck Index, 11th ed) The name is derived from Kao-ling (Chinese: "high ridge"), the original site. (From Grant & Hackh's Chemical Dictionary, 5th ed)
  • MENTHOL 1 g/100g - A monoterpene cyclohexanol produced from mint oils.
  • ZINC OXIDE 12.5 g/100g - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.

No More Products Active Ingredients UNII Codes

No More Products 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.

No More Products 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



Other



Drug Facts


Otc - Active Ingredient



Active Ingredients

Glycerin      25%
Kaolin        12.5%
Calamine   12.5%
Menthol        1%


Otc - Purpose



Purposes

Glycerin ....................................................Protectant
Kaolin .........................................Protectant/Anti-Itch
Calamine ....................................Protectant/Anti-Itch
Menthol .....................................................Analgesic


Indications & Usage



Uses • Helps relieve the itching and discomfort associated with anorectal disorders •
Provides temporary relief from the symptoms of perianal skin irritation • For the temporary
relief of itching associated with moist anorectal conditions • For the temporary relief of
irritation and burning


Warnings



Warnings
For rectal use only
Do not use unless a prior doctor’s diagnosis of anorectal condition has been made
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days
• allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain,
other symptoms develop or increase • Do not put this product into the rectum by using fingers or any
mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product
because they interfere with the ability of this product to adhere properly to the skin area.
If pregnant or breastfeeding, ask a health professional before use


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away


Dosage & Administration



Directions
Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply a pea size amount of cream externally to the anal area and to the inner rim of the anus,
not deep into the rectum. • Children under 12 years of age: consult a doctor • Apply externally to the
affected area once or twice daily when pain or irritation is present.


Other Safety Information



Other Information: Do not use if tube seal is cut, broken or missing. • store at 15-30° C (59-86° F)


Inactive Ingredient



Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,
Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium Aluminum Silicate,
Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, Silica, Stearyl Alcohol


Otc - Questions



Questions or Comments? Email: [email protected]


No More Product Labeling



No More Products

Net Wt. 1.25oz (35g)

Manufactured by Sarati Intn'i, 27502 Ted Hunt Rd., Los Fresnos TX  78566

www.nomoreproducts.com

No More Fissure Box

No More Fissure Tube

No More Hemorrhoids Box

No More Hemorrhoids Tube

No More Pruritus Box

No More Pruritus Tube

RES


* Please review the disclaimer below.