NDC 71226-003 Painbloc24 Prowomen Pain Relief Patch

Natural Menthol

NDC Product Code 71226-003

NDC 71226-003-20

Package Description: 10 PATCH in 1 CARTON

NDC Product Information

Painbloc24 Prowomen Pain Relief Patch with NDC 71226-003 is a a human over the counter drug product labeled by Vizuri Health Sciences Llc. The generic name of Painbloc24 Prowomen Pain Relief Patch is natural menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Vizuri Health Sciences Llc

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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 Prowomen Pain Relief Patch 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.

  • MENTHOL, UNSPECIFIED FORM 6 g/1

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.

  • CHASTE TREE FRUIT (UNII: 433OSF3U8A)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • CITRUS PARADISI SEED (UNII: 12F08874Y7)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WHITE CURRANT (UNII: H415EVM0YK)

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: 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: 03-18-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Painbloc24 Prowomen Pain Relief Patch Product Label Images

Painbloc24 Prowomen Pain Relief Patch 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

Menthol 6%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated


with:


▪ simple backache


▪ muscle strains


▪ arthritis


▪ bruises


▪ sprains

Warnings

For external use onlyWhen using this product▪ use only as directed


▪ do not bandage tightly


▪ do not use with heating pad


▪ avoid contact with eyes and mucous membranes


▪ do not apply to wounds, damaged, broken or irritated skin


▪ do not use at the same time as other topical analgesics


Stop use and ask a doctor if▪ condition worsens


▪ redness or irritation develops


▪ symptoms last more than 7 days or clear up and occur again within a few days


▪ you experience burning, swelling or blistering where applied


If pregnant or breast-feeding ask a healthcare professional before use.

Keep Out Of Reach Of Children

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

Directions

  • Adults and children over 12 years:▪ clean and dry affected area
  • ▪ trim excessive hair for better adhesion
  • ▪ open pouch and remove patch
  • ▪ remove backing from patch by grasping both ends and pulling backing apart
  • ▪ peel off one half of backing and place patch onto affected area
  • ▪ peel off other half of backing and press and smooth onto skin
  • Use patch as needed for up to 8 hours. Do not remove when wet or directly after showering or bathing. Allow patch to dry and then slowly remove.use on affected area no more than 3-4 times daily.Children under 12 years : consult doctor

Other Information

Store in cool dry place at room temperature

Inactive Ingredients

Acrylic Adhesive, Chaste Tree Berry (Vitex), d-limonene, Dipropylene glycol, Lavender,


Lemon Balm, Magnesium Chloride, Polysorbate 80, Tocopheryl Acetate, White Curcumin

* Please review the disclaimer below.