NDC 73045-004 Cbd Unlimited Topical Analgesic

Menthol And Camphor

NDC Product Code 73045-004

NDC 73045-004-01

Package Description: 15 mL in 1 BOTTLE, SPRAY

NDC 73045-004-02

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC 73045-004-03

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC Product Information

Cbd Unlimited Topical Analgesic with NDC 73045-004 is a a human over the counter drug product labeled by Endexx Corporation. The generic name of Cbd Unlimited Topical Analgesic is menthol and camphor. The product's dosage form is spray and is administered via topical form.

Labeler Name: Endexx Corporation

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Cbd Unlimited Topical Analgesic 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 50 mg/mL
  • CAMPHOR OIL 325 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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CLOVE OIL (UNII: 578389D6D0)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
  • CANNABIDIOL (UNII: 19GBJ60SN5)

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: Endexx Corporation
Labeler Code: 73045
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: 05-05-2020 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 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.

Cbd Unlimited Topical Analgesic Product Label Images

Cbd Unlimited Topical Analgesic 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 USP 5%Camphor 3.25%

Purpose

Topical Analgesic

Uses

Temporary relief from minor aches and pains of muscles & joints associated with: arthritis, simple backache, strains, sprains

Warnings:

For external use only.When using this product:• use only as directed• do not bandage tightly or use with a heating pad• avoid contact with eyes and mucous membranes• do not apply to wounds or damaged, broken or irritated skin• do not spray onto face• avoid inhaling spray mist and fumesStop use and ask doctor if:• condition worsens• redness is present• irritation develops• symptoms persist for more than 7 days or clears up and occurs again within a few daysFlammable do not use near heat or open flame or while smokingIf pregnant or breast-feeding, ask a healthcare professional before use

Keep Out Of Reach Of Children

If product is swallowed get medical help or contact a Poison Control Center right away.

Directions:

FOR EXTERNAL USE ONLY:Shake Before UsingAdults and children 12 years of age and older:Spray on affected areas 1 to 4 times daily.Avoid contact with eyes and mouth.

Inactive Ingredients

Arnica Extract (Glycerin, Water, Arnica Montana Flower Extract), Clove Bud Oil, Eucalyptus Globulus Leaf Oil, Hemp-Derived Cannabidiol Isolate, Isopropyl Alcohol, Methylsulfonylmethane (MSM), Wintergreen Oil (Methyl Salicylate)

* Please review the disclaimer below.