NDC 72614-265 Canna Numb Roll On

Lidocaine Hydrochloride, Menthol

NDC Product Code 72614-265

NDC 72614-265-02

Package Description: 73 mL in 1 CONTAINER

NDC Product Information

Canna Numb Roll On with NDC 72614-265 is a a human over the counter drug product labeled by Hempagenix, Llc. The generic name of Canna Numb Roll On is lidocaine hydrochloride, menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Hempagenix, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Canna Numb Roll On 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.

  • LIDOCAINE HYDROCHLORIDE 40 mg/mL
  • MENTHOL 10 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.

  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Hempagenix, Llc
Labeler Code: 72614
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: 10-01-2018 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: 12-31-2019 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.

Canna Numb Roll On Product Label Images

Canna Numb Roll On 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 Ingredients

Lidocaine HCl 4%Menthol 1%

Purpose

Topical AnestheticTopical Analgesic

Uses:

  • Temporarily relieves minor pain

Warnings:

For external use only.

Do Not Use

  • On large areas of the body or on cut, irritated or swollen skin on puncture woundsfor more than one week without consulting a doctor

When Using This Product

  • Use only as directed. Read and follow directions and warnings on this package.Avoid contact with eyes and mucous membranesrare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of usea transient burning sensation may occur upon application but generally disappears in several daysavoid applying into skin folds

Stop Use And Ask A Doctor If

  • Conditions worsensredeness is presentirritation develops symptoms persist for more than 7 days or clear up and occur again within a few daysyou experience signs of skin injury, such as pain, swelling, or blistering where the product was appliedFlammable - keep away from fire or flame

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children And Pets.

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

Directions:

  • Adults and children over 12 years:apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour periodmassage into painful area until thoroughly absorbed into skin children 12 years or younger: ask a doctor

Inactive Ingredients:

Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil, Carbomer, Citrus Aurantium Dulcis (Orange) Oil, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguayensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylemthane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, Salix Nigra (Willow) Bark Extract, Sd-Alcohol 40B, Triethanolamine.

* Please review the disclaimer below.