NDC 62742-4177 Cannaflex

Trolamine Salicylate

NDC Product Code 62742-4177

NDC 62742-4177-2

Package Description: 1 TUBE in 1 CARTON > 45 mL in 1 TUBE (62742-4177-1)

NDC Product Information

Cannaflex with NDC 62742-4177 is a a human over the counter drug product labeled by Allure Labs Inc.. The generic name of Cannaflex 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.

Cannaflex 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/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)
  • COCONUT ALKANES (UNII: 1E5KJY107T)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HORSE CHESTNUT (UNII: 3C18L6RJAZ)
  • ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
  • 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • MENTHOL (UNII: L7T10EIP3A)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)

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: 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: 10-16-2019 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: 12-31-2020 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.

Cannaflex Product Label Images

Cannaflex 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: Temporarily relieves minor pain associated with arthritis, backache, muscle strains, muscle sprains, bruises, cramps.

Warnings

Warning: For external use only.

Otc - Ask Doctor

Allergy alert if prone to allergic reaction from aspirin or salicylates, consult a Doctor before use.

Otc - When Using

When using this product: Use only as directed. Read and follow all directions and warnings on this label. Do not bandage tightly or use with a heated pad. Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. Do not use at the same time with other topical analgesics.

Otc - Stop Use

Stop use and ask a doctor if condition worsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. Redness is persistent. Irritation develops.

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

Inactive Ingredient

Inactive ingredients: Water, Coconut Alkanes, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Methyl Sulfonyl Methane, Stearic Acid, Glycerin, Aesculus Hippocastannum (Horse Chestnut) Seed Extract, Rosa Moschata Seed Oil, Menthoxypropanediol, Sorbitan Olivate, Cannabidiol (From full spectrum hemp extract), Medium Chain Triglyceride, Cetearyl Olivate, Phenoxyethanol, Menthyl Lactate, Tocopherol, Mentha Piperita (Pepperment) Oil, Cetyl Palmitate, Sorbitan Palmitate, Coco-Caprylate/Caprate, Caprylyl Glycol, Menthol, Xanthan Gum, Ethylhexylglycerin, Hexylene Glycol, Vanillyl Butyl Ether.

Dosage & Administration

Adults and Children over 12 years: Apply generously to affected area. Massage into painful area until thoroughly asborbed into skin. Repeat as necessary, But no more than 4 times daily.

Otc - Questions

Questions or Comments? Call our customer service department at: 1-800-898-5153

* Please review the disclaimer below.