NDC 73287-005 Hempvana Cold As Ice Pain Relief Gel-patch

Menthol

NDC Product Code 73287-005

NDC 73287-005-01

Package Description: 7 PATCH in 1 CARTON > 8 g in 1 PATCH

NDC Product Information

Hempvana Cold As Ice Pain Relief Gel-patch with NDC 73287-005 is a a human over the counter drug product labeled by Telebrands Corp. The generic name of Hempvana Cold As Ice Pain Relief Gel-patch is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Telebrands Corp

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.

Hempvana Cold As Ice Pain Relief Gel-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 5 g/100g

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.

  • WATER (UNII: 059QF0KO0R)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Telebrands Corp
Labeler Code: 73287
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: 11-15-2019 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: 12-31-2020 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.

Hempvana Cold As Ice Pain Relief Gel-patch Product Label Images

Hempvana Cold As Ice Pain Relief Gel-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 5%

Purpose

Menthol 5%................Topical Anesthetic

Uses

temporarily relief of pain

Warnings

For external use only

Otc - Do Not Use

  • Do not usemore than one patch at a timeon wounds, cuts, damaged, broken and/or irritated skinover raw surfaces or blistered areasat the same time as other topical analgesicsif allergic to menthol or any inactive ingredientsif package is damaged or opened

Otc - When Using

  • When using this productUse only as directed. Read and follow all directions and warnings on this labelDo not bandage tightly or apply local heat (such as heating pads) to the area of useAvoid contact with eyes or mucous membranes

Otc - Stop Use

  • Stop use and ask a doctor ifCondition worsensSymptoms persist for more than 7 days or clear up and occur again within a few daysRedness is present or irritation develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults and children over 12 years of ageClean and dry affected areafollow application insructions above to apply patch to skinApply one patch to affected area no more than 3-4 times dailyRemove patch from affected area after maximum of 8 hour applicationChildren uner 12 years of age: consult a doctor

Storage And Handling

  • Avoid storing patches in direct sunlight. Protect patches from excessive moisture

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium polyacrylate,Tartaric Acid, Titanium Dioxide, Water

Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

* Please review the disclaimer below.