NDC 73529-250 Cbdrelief Pain Relief Body

Trolamine Salicylate 10%

NDC Product Code 73529-250

NDC 73529-250-01

Package Description: 1 TUBE in 1 CARTON > 40 g in 1 TUBE

NDC Product Information

Cbdrelief Pain Relief Body with NDC 73529-250 is a a human over the counter drug product labeled by Nutritech Pharmaceuticals, Inc.. The generic name of Cbdrelief Pain Relief Body is trolamine salicylate 10%. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Nutritech Pharmaceuticals, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Cbdrelief Pain Relief Body 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.

  • TROLAMINE SALICYLATE 10 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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TRIETHANOLAMINE OLEATE (UNII: DZ7P3IE35F)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HEMP (UNII: TD1MUT01Q7)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • DIMETHICONE 100 (UNII: RO266O364U)

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: Nutritech Pharmaceuticals, Inc.
Labeler Code: 73529
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: 02-11-2020 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.

Cbdrelief Pain Relief Body Product Label Images

Cbdrelief Pain Relief Body 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

Trolamine Salicylate 10%

Purpose

Trolamine Salicylate 10%........Topical Analgesic

Uses

Temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Warnings

  • WarningsFor external use onlyAllergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
  • When using this productuse only as directeddo not bandage tightly or use with a heating padavoid contact with eyes or mucos membranesdo not apply to wounds or damaged skinStop use and ask doctor if condition worsenssymptoms persist for more than 7 days or clear up and occur again within a few daysredness is present n irritation developsIf pregnant or breast-feeding, ask a health professional before use.
  • In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • DirectionsAdults and children over 12 years of age: apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than 4 times dailyChildren 12 years or younger: ask a doctor

Inactive Ingredients

Inactive IngredientsPurified Water, CBD Hemp Oil, Stearic Acid, Cetyl Alcohol, Glyceryl Stearate, Aloe Vera, Triethanolamine, Dimethicone, Propyl Paraben, Methylparaben, Carbomer, Iodopropynyl Butylcarbamate

* Please review the disclaimer below.