NDC 73287-012 Hempvana Cold As Ice Gel

Menthol

NDC Product Code 73287-012

NDC 73287-012-01

Package Description: 1 TUBE in 1 CARTON > 118 mL in 1 TUBE

NDC Product Information

Hempvana Cold As Ice Gel with NDC 73287-012 is a a human over the counter drug product labeled by Telebrands Corp. The generic name of Hempvana Cold As Ice Gel is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Telebrands Corp

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Gel 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 8 mg/100mL

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 MYRISTATE (UNII: 0RE8K4LNJS)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • CAMPHOR, (-)- (UNII: 213N3S8275)
  • TURMERIC (UNII: 856YO1Z64F)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ALCOHOL (UNII: 3K9958V90M)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)

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: 07-07-2020 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.

Hempvana Cold As Ice Gel Product Label Images

Hempvana Cold As Ice Gel 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 8% w/w

Purpose

Menthol USP 8% w/w................Topical Analgesic

Uses

Temporarily relief of minor aches and pains of muscles and joints associated with:• simple backache • arthritis • strains • bruises • sprains

Warnings

For external use onlyFlammable: Keep away from excessive heat or open flame

Otc - When Using

  • When using this product, avoid contact with eyes.Do not apply to wounds or damaged skinDo nut use in large quantities, particularly over raw surfaces or blistered areas.Do not bandage tightly

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 days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or nursing, ask a healthcare professional before using.

Directions

Adults: Apply to affected are not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water.
For children under 18 years of age: Consult a physician.

Other Information

Store tightly closed in a cool dry place.

Inactive Ingredients

Water/aqua/eau, alcohol denat., isopropyl myristate, sodium hydroxide, silica silylate, hemp seed oil, camphor, aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, curcuma longa (turmeric) root extract, ilex paraguariensis leaf extract, melissa officinalis flower/leaf/stem extract, phenoxyethanol, carbomer, ethylhexylglycerin, disodium edta, tocopheryl acetate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).

Description

Call (855) 877-4503 (M-F, 9am-5pm EST)Does not contain NSAIDS, ibuprofen, Aspirin or SalicylateFor more information visit www.hempvana.comDist. By: Telebrands Corp.79 Two Bridges RoadFairfield, NJ 07004

* Please review the disclaimer below.