NDC 72342-130 Pain Relief Extra Strength, Cooling

Menthol, Unspecified Form

NDC Product Code 72342-130

NDC 72342-130-18

Package Description: 118 mL in 1 BOTTLE, SPRAY

NDC Product Information

Pain Relief Extra Strength, Cooling with NDC 72342-130 is a a human over the counter drug product labeled by J.r. Watkins, Llc.. The generic name of Pain Relief Extra Strength, Cooling is menthol, unspecified form. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: J.r. Watkins, Llc.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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 Relief Extra Strength, Cooling 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, UNSPECIFIED FORM 6 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)

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: 12-15-2020 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.

Pain Relief Extra Strength, Cooling Product Label Images

Pain Relief Extra Strength, Cooling 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

Active Ingredient

Menthol 6%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated withsimple backachearthritisstrainsbruisessprains

Warnings

For external use only.Flammable: Keep away from fire or flame and heated surfaces.

Do Not Use

  • On open wounds, damaged or irritated skinWith a heading pad or TENS deviceWith any other creams, ointments, sprays, liniments, or other topical products containing menthol

When Using This Product

  • Do not bandage tightlyUse only as directedAvoid contact with eyes or mucous membranesContents under pressureDo not puncture or incinerateDo not store at temperature above 120 deg. F

Stop Use And Ask A Doctor If

  • Condition worsensyou have sensitive skinRash, itching, redness, or excessive irritation of skin developsSymptoms persist for more than 7 daysSymptoms clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding: 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 Center right away.

Directions

  • Adults and children 12 years of age and older:Apply to affected area not more 4 times a dayMassage painful area until absorbed into skinWash hands after each use with cold waterChildren under 12 years of age: consult a doctor.

Other Information

  • Store away from childrenStore in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive Ingredients

Aloe barbadensis leaf extract, Arnica montana flower extract, denatured alcohol, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, tocopheryl acetate (vitamin E), water

* Please review the disclaimer below.