NDC 72749-000 Painfix Restore

Menthol

NDC Product Code 72749-000

NDC Product Information

Painfix Restore with NDC 72749-000 is a a human over the counter drug product labeled by Painfix Llc. The generic name of Painfix Restore is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Painfix Llc

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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 Restore Active Ingredient(s)

Additional informationCallout TooltipWhat 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 30 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • TARTARIC ACID (UNII: W4888I119H)
  • WATER (UNII: 059QF0KO0R)
  • DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
  • TURMERIC (UNII: 856YO1Z64F)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Restore Product Label Images

Painfix Restore 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 3%

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:open pouch and remove patchpeel off protective backing and carefully apply sticky side to affected areaif affected area is large, use more than one patch for best resultsuse each patch for up to 15 hoursapply a new patch each dayto better keep the patch in place, use the provided adhesive plastersfor best results, use with recommended exercisesChildren 12 years and younger, ask a health professional

Other Information

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

Ingredients

Aloe barbadensis extract, Aluminum glycinate, Angelica anomala extract, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract, Curcuma zedoaria extract, Daemonops draco extract, Disodium EDTA, Drynaria fortunei extract, Glycerine, Glyceryl stearate, Kaolin, Methylparaben, PEG-40 hydrogenated castor oil, Pistacia lentiscus extract, Polyvinylpyrrolidone, Rheum officinale extract, Sodium polyacrylate, Scutellaria baicalenis extract, Tartaric acid, Water (Aqua)

* Please review the disclaimer below.

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