NDC 72749-001 Painfix Relief

Menthol

NDC Product Code 72749-001

NDC Product Information

Painfix Relief with NDC 72749-001 is a a human over the counter drug product labeled by Painfix Llc. The generic name of Painfix Relief is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Painfix Llc

Dosage Form: Gel - 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.

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.


Painfix Relief 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 50 mg/g

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.

  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • TURMERIC (UNII: 856YO1Z64F)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Painfix Llc
Labeler Code: 72749
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: 02-01-2019 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: 12-31-2019 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.

Painfix Relief Product Label Images

Painfix Relief 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 5%

Purpose

`Topical analgesic

Uses

Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonits • cramps • strains • bruises • sprains

Warnings

Avoid direct contact with eyes. For external use only.

When Using This Product

• use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

Stop Use And Ask A Doctor If

• condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Directions

  • Adults and children above 12 years:apply gel to affected area(s) and massage gently until thoroughly absorbed into skinrepeat up to 3 to 4 times per day, on an as needed basisafter applying, wash hands with soap and waterChildren 12 years and younger, ask a health professional

Other Information

Store in a cool, dry place, away from direct sunlight.

Ingredients

Aloe barbadensis extract, Angelica anomala extract, Caprylyl glycol (and) Phenethyl alcohol, Carbomer, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract,


Curcuma zedoaria extract, Daemonops draco extract, Drynaria fortunei extract, Glycerin, Pistacia lentiscus extract, Propylene glycol, Rheum officinale extract, Scutellaria baicalenis extract, Water (Aqua)

* Please review the disclaimer below.

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