NDC 62742-4198 Cbd Pain Relief Cream

Trolamine Salicylate

NDC Product Code 62742-4198

NDC 62742-4198-1

Package Description: 57 g in 1 TUBE

NDC Product Information

Cbd Pain Relief Cream with NDC 62742-4198 is a a human over the counter drug product labeled by Allure Labs Inc. The generic name of Cbd Pain Relief Cream is trolamine salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Allure Labs 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 Pain Relief Cream 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 100 mg/g

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.

  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • COCONUT ALKANES (UNII: 1E5KJY107T)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
  • VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)

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: Allure Labs Inc
Labeler Code: 62742
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: 12-17-2020 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 Pain Relief Cream Product Label Images

Cbd Pain Relief Cream 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

Otc - Active Ingredient

Active Ingredients: Trolamine Salicylate 10%

Otc - Purpose

Purpose: Topical Analgesic

Indications & Usage

Uses: For temporary relief of minor aches and pains of the muscles and joints (such as arthritis, backache, sprains and bruises).

Warnings

  • Warnings:For external use onlyKeep out of reach of children

Otc - When Using

  • When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact eith eyes or mucus membranesdo not apply to wounds or damaged skin

Otc - Stop Use

  • Stop use and ask a doctor if: Condition worsenssymptoms persists for more tham 7 days or clear up and occurs again within few days.Redness is presentirritaiotn develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breat feedingAsk a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:Adults and children over 12 years of age:

• Apply generously to affected area

• massage into painful area until thoroughly absorbed into skin

• repeat as necessary, but no more than 4 times daily

Otc - Ask Doctor

Children 12 years or younger:

• Ask a doctor

Other Safety Information

Other Information

• Store at room temperature
ALLERGY ALERT - If prone to allergic reaction from aspirin orsalicylates, consult a doctor before use.

Inactive Ingredient

Inactive Ingredients: Water (Aqua), Coconut Alkanes*, Sorbitan Olivate*, Cetearyl Olivate*, Glycerin*, Dimethyl Sulfone, Glyceryl Stearate*,Cannabidiol (From Hemp Extract), Stearic Acid*, Cetyl Palmitate*, Rosa Moschata Seed Oil*, Cetearyl Alcohol, Ceteareth-20, Sorbitan Palmitate*, Tocopherol, Vanillyl Butyl Ether, Coco-Caprylate/Caprate*, Caprylhydroxamic acid*, Glyceryl Caprylate*, Xanthan Gum*

* Please review the disclaimer below.