NDC 76348-640 Pain Therapy

Menthol, Methyl Salicylate

NDC Product Code 76348-640

NDC 76348-640-04

Package Description: 112 g in 1 TUBE

NDC 76348-640-05

Package Description: 112 g in 1 JAR

NDC Product Information

Pain Therapy with NDC 76348-640 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Pain Therapy is menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Renu Laboratories, 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.

Pain Therapy 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.

  • MENTHOL 2.24 g/112g
  • METHYL SALICYLATE 11.2 g/112g
  • MENTHOL 2.24 g/112g
  • METHYL SALICYLATE 11.2 g/112g

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.

  • PEG-100 STEARATE (UNII: YD01N1999R)
  • TABASCO PEPPER (UNII: J1M3NA843L)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • LAURETH-7 (UNII: Z95S6G8201)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
  • EMU OIL (UNII: 344821WD61)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • WATER (UNII: 059QF0KO0R)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 05-14-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Pain Therapy Product Label Images

Pain Therapy 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

Menthol 2%Methyl Salicylate 10%

Purpose

Topical AnalgesicTopical Analgesic

Uses

Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises

Warnings

For external use only

When Using This Product

  • Do not apply to wounds or damaged skinDo not bandage tightlyDo not use in or near eyes; if product gets into eyes rinse thoroughly with waterDo not use with an electric heating pad

Stop Use And Ask Doctor If

  • Conditions worsenSymptoms last for more than 7 days or clear up and occur again within a few daysA rash or irritation develops

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Inactive Ingredients

Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

Arctic Heat

Dual Active Botanical Warming Formula with Emu Oil

Otc - Questions

Manufactured by:Renu Labs Inc.Ivyland, PA 18974www.RenuLabs.com

Dosage & Administration

DirectionsAdults and children 12 years of age andolder: Apply directly to affected area no more than 3 to 4 times daily.

Recent Major Changes

No major changes to any section.This is a simple product name change.

* Please review the disclaimer below.