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)

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.

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 withArthritissimple 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 oontact 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 sunlightAvoid taking a bath or shower, strenuous exercise or swimming 1 hourbefore or after applyingA temporary burning sensation 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 occurs You experience difficulty breathing or swallowingCondition worsensRedness is presentlrritation developsSymptoms last more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

​If prenant 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 to affaceted area using roller ball until visibly moistAllow to dryRepeat application, as needed, every 12 to 24 hoursDo not use more than twice a dayWash hands with soad and water after each applicationMay take several days to reach full effect.

Inactive Ingredients

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

Questions:

Call 855-438-3944

* Please review the disclaimer below.