NDC 72360-341 Douleurin Ice Pain Relief

Methyl Salicylate, Menthol

NDC Product Code 72360-341

NDC 72360-341-00

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

Douleurin Ice Pain Relief with NDC 72360-341 is a a human over the counter drug product labeled by Ventriq, Llc. The generic name of Douleurin Ice Pain Relief is methyl salicylate, menthol. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Ventriq, Llc

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.

Douleurin Ice Pain Relief 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.

  • METHYL SALICYLATE 100 mg/mL
  • MENTHOL 40 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CAPSAICIN (UNII: S07O44R1ZM)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LICORICE (UNII: 61ZBX54883)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • PANTOTHENIC ACID (UNII: 19F5HK2737)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • SQUALANE (UNII: GW89575KF9)
  • EDETATE SODIUM (UNII: MP1J8420LU)

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: Ventriq, Llc
Labeler Code: 72360
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: 02-01-2020 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.

Douleurin Ice Pain Relief Product Label Images

Douleurin Ice Pain Relief 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:

Methyl Salicylate 10%Menthol 4%

Purpose

Topical Analgesic

Uses:

Temporarily relieves inflammation, mild aches and pains of muscle joints.

Warnings:

Only for external use.

Do Not Use:

On open wounds, cuts damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucosus membranes.

Consult Your Physician:

  • If pain is persistent or worsens or if using any other topical pain products.Call poison control if swallowed. If contact with eyes occurs, rinse eyes thoroughly with cold water.

Keep Out Of Reach Of Children.

Consult physician for children under 12.

Directions: (Store In A Cool Dry Place)

Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately aftwards and avoid contact with eyes.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cannabis Sativus (Full Spectrum Hemp) Seed Oil, Capsaicin, Chamomilla Recutita (Chamomile) Extract, Cetearyl Olivate, Cetyl Alcohol, Cetyl Myristoleate, Chondroitin Sulfate, Gluconolactone, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) oil, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonylmethane (MSM), Magnesium Sulfate, Pantothenic Acid (Vitamin B5), Pyridoxine (Vitamin B6), Salix Nigra (Willow) Bark Extract, Sodium Benzoate, Sorbitan Olivate, Squalane, Tetrasodium EDTA

* Please review the disclaimer below.