NDC 73180-005 Qr Pain


NDC Product Information

Qr Pain with NDC 73180-005 is a a human over the counter drug product labeled by Maryhelene Enterprises Inc. The generic name of Qr Pain is analgesic. The product's dosage form is cream and is administered via topical form.

Labeler Name: Maryhelene Enterprises 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.

Qr Pain 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.

  • MANNITOL 30 g/100g
  • MENTHOL 1.25 g/100g

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)
  • 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.
  • 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: Maryhelene Enterprises Inc
Labeler Code: 73180
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: 12-01-2019 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: 12-31-2021 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.

Qr Pain Product Label Images

Qr Pain 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 Ingredient

Mannitol 30%Menthol 1.25%


Topical Analgesic


For the temporary relief of pain.


For external use only.

When Using This Product

  • Do not bandage tightlyavoid contact with the eyesdo not apply to wounds or damaged skindo not use with heating pads or other heating devicesas with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this productdo not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use And Ask A Doctor If

Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

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


Adults and children 12 years of age and older, apply to affected area no more than 3-4 times a day.
Children under 12 years of age: do not use, contact a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Lecithin, Ethylhexylglycerin, Ceteareth 20, Glyceryl stearate, Octyldodecanol, Phenoxyethanol, Propylene glycol, Isopropyl Palmitate, Caprylic/Capric triglyceride, Dimethicone, Polyethylene glycol 100 stearate, Water, Cetearyl alcohol.

* Please review the disclaimer below.