NDC 71226-001 Painbloc24

Capsaicin 0.25%

NDC Product Code 71226-001

NDC 71226-001-01

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 30 mL in 1 BOTTLE, WITH APPLICATOR

NDC 71226-001-02

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 14 mL in 1 BOTTLE, WITH APPLICATOR

NDC 71226-001-03

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 45 mL in 1 BOTTLE, WITH APPLICATOR

NDC 71226-001-06

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 12 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Painbloc24 with NDC 71226-001 is a a human over the counter drug product labeled by Vizuri Health Sciences Llc. The generic name of Painbloc24 is capsaicin 0.25%. The product's dosage form is solution and is administered via topical form.

Labeler Name: Vizuri Health Sciences Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Painbloc24 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.

  • CAPSAICIN 2.5 mg/mL
  • CAPSAICIN 2.5 mg/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5)

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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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: Vizuri Health Sciences Llc
Labeler Code: 71226
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-21-2017 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.

Painbloc24 Product Label Images

Painbloc24 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

Capsaicin 0.25%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:ArthritisSimple backacheMuscle strainsBruisesSprains

Warnings

For external use only

When Using This Product

  • Use only as directedDo not bandage tightly or cover treated areaDo not use with heating padAvoid contact with eyes and mucous membranesDo not apply to wounds, damaged, broken or irritated skinDo not expose the area treated with product to heat or direct sunlightIf using before exercise, showering or swimming, apply, wait 30 minutes, then wash off before participatingA temporary burning sensation and/or redness may occur upon application. This is normal and generally stops after a few days of use

Stop Use And Ask A Doctor If

  • Severe burning sensation occursYou experience difficulty breathing or swallowingCondition worsensRedness persists, spreads or becomes tenderIrritation developsSymptoms last more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare 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.

Directions

  • Adults over 18 years:Apply by holding Pain Pen straight down and press tip repeatedly on to affected area until liquid flows. Then dab sparingly.Allow to dryRepeat application, as needed, every 12 to 24 hoursDo not use more than twice a dayWash hands with soap and water after each application. If applying to hand, wait 30minutes, then wash with soap and cold water after each application.If soap does not completely remove all product residues, try using skin or mineral oil.May take several days to reach full effect

Inactive Ingredients

Alcohol, Diethylene Glycol Monoethyl Ether, Hyaluronate Sodium, Polysorbate 80, Pramoxine HCl, Propylene Glycol, Water

Questions

Call 855-438-3944

Other

Distributed by Vizuri Consumer Healthcare


Fairfax, VA 22033 U.S.A.

* Please review the disclaimer below.