NDC 72342-050 Pain Relieving Liniment

Camphor (natural) And Menthol, Unspecified Form

NDC Product Code 72342-050

NDC 72342-050-18

Package Description: 1 BOTTLE, SPRAY in 1 BOX > 118 mL in 1 BOTTLE, SPRAY

NDC Product Information

Pain Relieving Liniment with NDC 72342-050 is a a human over the counter drug product labeled by J.r. Watkins, Llc.. The generic name of Pain Relieving Liniment is camphor (natural) and menthol, unspecified form. The product's dosage form is spray and is administered via topical form.

Labeler Name: J.r. Watkins, Llc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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 Relieving Liniment 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.

  • CAMPHOR (NATURAL) 3.5 g/100mL
  • MENTHOL, UNSPECIFIED FORM 2.5 g/100mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • THYMOL (UNII: 3J50XA376E)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

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: J.r. Watkins, Llc.
Labeler Code: 72342
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: 09-01-2019 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.

Pain Relieving Liniment Product Label Images

Pain Relieving Liniment 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

Other

Drug Facts

Flammable: Keep away from fire or flame.

Otc - Purpose

Active ingredientsPurposeCAMPHOR 3.5%EXTERNAL ANALGESICMENTHOL 2.5%EXTERNAL ANALGESIC

Uses

  • Temporarily relieves minor aches and pains of muscles and joints associated withsimple backachestrainsbruisessprainsarthritis

Warnings

For external use only

Otc - When Using

  • When using this productavoid contact with eyes, nostrils and mouthdo not bandage tightlydo not apply to wounds or damaged skin

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysrash or irritation occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults and children 2 years and older: Apply to affected area not more than 3-4 times daily.Children under 2 years of age: Ask a doctor.

Other Information

  • Do not purchase if tamper evident seals are not intactclose container tightly and store at room temperature away from heat (dry, well-ventilated premises at 59-77°F)

Inactive Ingredients

Eucalyptus globulus leaf oil, polysorbate 20, SD Alcohol 40B, thymol, water.

* Please review the disclaimer below.