NDC 82988-101 Ice Blue Pain Alleviating Rub
Menthol, Unspecified Form, Methyl Salicylate, Camphor (natural) Gel Topical

Product Information

What is NDC 82988-101?

The NDC code 82988-101 is assigned by the FDA to the product Ice Blue Pain Alleviating Rub which is a human over the counter drug product labeled by Lemisol Corporation. The generic name of Ice Blue Pain Alleviating Rub is menthol, unspecified form, methyl salicylate, camphor (natural). The product's dosage form is gel and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 82988-101-08 226.7 g in 1 jar , 82988-101-16 453.5 g in 1 jar . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code82988-101
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Ice Blue Pain Alleviating Rub
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Menthol, Unspecified Form, Methyl Salicylate, Camphor (natural)
Product Type 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.		Human Otc Drug
Dosage FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.		Lemisol Corporation
Labeler Code82988
FDA Application Number 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.		part348
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		08-31-2022
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Ice Blue Pain Alleviating Rub?


Product Packages

NDC Code 82988-101-08

Package Description: 226.7 g in 1 JAR

NDC Code 82988-101-16

Package Description: 453.5 g in 1 JAR

Product Details

What are Ice Blue Pain Alleviating Rub Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Ice Blue Pain Alleviating Rub Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2624202 - camphor 0.3 % / menthol 2.5 % / methyl salicylate 2.2 % Topical Gel
  • RxCUI: 2624202 - camphor 0.003 MG/MG / menthol 0.025 MG/MG / methyl salicylate 0.022 MG/MG Topical Gel
  • RxCUI: 2624203 - camphor 3 % / menthol 5 % / methyl salicylate 8 % Topical Spray
  • RxCUI: 2624203 - camphor 30 MG/ML / menthol 50 MG/ML / methyl salicylate 80 MG/ML Topical Spray

Ice Blue Pain Alleviating Rub Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Ice Blue Pain Alleviating Rub Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts


Active Ingredients



Methyl Salicylate8%

Menthol 5.0%

Camphor 3.0%


Purpose



Topical analgesic

Topical analgesic

Topical analgesic


Indications & Usage



Uses provides temporary relief of minor aches and pains in muscles and joints associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings:



For external use only


Otc - When Using



When using this product use only as directed

  • do not bandage or apply heating pads
  • do not apply to wounds or damaged skin
  • avoid contact with eyes and mucous membranes

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens
  • irritation develops
  • symptoms persist for more than 8 days or clear up and return

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 swallowed get medical help or contact a Poison Control immediately.


Adults And Children Over 12 Years:



Apply generously to affected area

Massage until gel is completely absorbed by skin. Repeat as necessary


Inactive Ingredients



DMDM Hydantoin, Eucalyptus Globulus Leaf Oil, FD&C Blue No 1, Glycerin, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Purified Water.


Principal Display Panel – 8 Oz Spray Label



Greaseless

SIN GRASA

Rx
Rysell®

ICE
BLUE®
FORTE

Principal Display Panel – 8 Oz Gel Label



Greaseless

SIN GRASA

Rx
Rysell®

ICE
BLUE®

Analgesic/ Analgésico

Gel

* Please review the disclaimer below.