NDC 64479-400 Cbd

Camphor (synthetic)

NDC Product Code 64479-400

NDC 64479-400-01

Package Description: 114 g in 1 JAR

NDC Product Information

Cbd with NDC 64479-400 is a a human over the counter drug product labeled by Smartscience Laboratories, Inc.. The generic name of Cbd is camphor (synthetic). The product's dosage form is cream and is administered via topical form.

Labeler Name: Smartscience Laboratories, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 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.

  • CAMPHOR (SYNTHETIC) 5 mg/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.

  • METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • CALCITRIOL (UNII: FXC9231JVH)
  • CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ESCIN (UNII: RUU8G67GQM)
  • GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • TROLAMINE SALICYLATE (UNII: H8O4040BHD)
  • 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: Smartscience Laboratories, Inc.
Labeler Code: 64479
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: 02-12-2020 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 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

Other

Drug Facts

Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, color may vary.

Manufactured cGMP by Smart Science Labs, 13760Reptron Blvd Tampa, FL. 33626

Active Ingredient

Camphor (5.0%)

Purpose

External Analgesic

Uses

  • Temporarily relieves foot, ankle and leg pain associated with:arthritismuscle achesmuscle strainsjoint pain

Directions

  • Use only as directedDo not use on children under 12 years of age.Apply onto affected area no more than four times daily.

Warnings

For external use only: Flammable: Keep away from excessive heat or open flame.

Otc - Ask Doctor

  • Ask a doctor before use if you have sensitive skin or if you are taking any blood thinners.

When Using This Product

  • Do not use on wounds or irritated skinDo not bandage tightly or use with a heating padWash hands after use with cool water

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. If accidentally swallowed, contact a doctor or poison control center immediately

Otc - Stop Use

  • Stop use and ask a doctor if condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days.

Inactive Ingredients

Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aescin (Horse Chestnut Extract), Aloe Vera, Arnica Montana Extract, C12-15 Alkyl Benzoate, Chondroitin Sulfate, Diazodinyl Urea, Dimethicone, Disodium EDTA, dl Panthenol, Fructoborate, Cannabis Sativa Oil (Hemp Derived), Glucosamine Sulfate, Glycerin, Glycerol Stearate, Hydroxypropyl methylcellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Shea Butter, Tocopheryl Acetate, Trolamine Salicylate

Otc - Questions

Questions or comments? Email info@invigcbd.com.

* Please review the disclaimer below.