NDC 71831-002 Pranicura

Glycerin, Kaolin, Calamine, Menthol

NDC Product Code 71831-002

NDC 71831-002-01

Package Description: 70 g in 1 JAR

NDC 71831-002-03

Package Description: 56 g in 1 JAR

NDC Product Information

Pranicura with NDC 71831-002 is a a human over the counter drug product labeled by Pranicura, Llc. The generic name of Pranicura is glycerin, kaolin, calamine, menthol. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - 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.

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.

Pranicura 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.

  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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: Pranicura, Llc
Labeler Code: 71831
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: 01-01-2019 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: 12-31-2021 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".

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Pranicura Product Label Images

Pranicura 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

Active IngredientsGlycerin 25% Kaolin 12.5% Calamine 12.5% Menthol 1%

Otc - Purpose

PurposesGlycerin ..........ProtectantKaolin .............Protectant/Anti-ItchCalamine .........Protectant/Anti-ItchMenthol ...........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 temporaryrelief of itching associated with moist anorectal conditions • For the temporary relief ofirritation and burning

Warnings

WarningsFor rectal use only

Otc - Do Not Use

Do not use unless a prior doctor's diagnosis of anorectal condition has been made

Otc - When Using

When using this product do not exceed the recommended daily dosage unlessdirected by a doctor

Otc - Stop Use

Stop use and ask a doctor if • bleeding occurs • condition worsens or does notimprove within 7 days • allergic reaction develops • symptoms being treated do notsubside 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 orapplicator.• Remove petrolatum or greasy ointment before using this product because theyinterfere with the ability of this product to adhere properly to the skin area

Otc - Pregnancy Or Breast Feeding

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 PoisonControl Center right away

Dosage & Administration

Directions• Adults: When practical, cleanse the affected area by patting or blotting with anappropriate cleansing wipe. Gently dry by patting or blotting with toilet tissue or a softcloth before application of this product.• For Pruritus Ani: Wait 20 seconds after drying. If the desire to scratch is gone, do notapply cream. If the desire to scratch continues, apply a fingertip amount of ointment toanal and perianal areas. Use finger cot or disposable gloves if desired. Rub or lightlyscratch (with fingertip, not fingernails) until the itch is satisfied.• For Anal Fissures: Apply a fingertip amount of cream to the anal area and to the innerrim of the anus.• Children under 12 years of age: consult a doctor• Apply externally to the affected area once or twice daily when pain or irritation fromanal fissures are present or ideally after bowel movement.

Other Safety Information

Other Information store at 15°-30° C (59°-86° F)

Inactive Ingredient

Inactive IngredientsAcrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,Isopropyl Palmitate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol,Stearyl Alcohol

Otc - Questions

Questions or Comments? Call weekdays 9 AM to 5 PM CST at 763-537-3419

Principal Display Package

PRANICURATHE PRURITUS ANI SOLUTIONAnorectal CreamNet Wt. 2.5 oz. (70 g)Manufactured for Pranicura, LLC by Sarati International, Inc.Los Fresnos, Texas 785662.5 oz. Jar2.0 oz. Jarres

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