NDC 81790-001 Relieve And Relax Pain Relieving

Camphor (synthetic), Menthol

NDC Product Code 81790-001

NDC 81790-001-00

Package Description: 88.7 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Relieve And Relax Pain Relieving with NDC 81790-001 is a a human over the counter drug product labeled by Mac Innovations, Llc. The generic name of Relieve And Relax Pain Relieving is camphor (synthetic), menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Mac Innovations, 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.

Relieve And Relax Pain Relieving 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 (SYNTHETIC) 40 mg/mL
  • MENTHOL 100 mg/mL

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)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 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: Mac Innovations, Llc
Labeler Code: 81790
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: 06-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Relieve And Relax Pain Relieving Product Label Images

Relieve And Relax Pain Relieving 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

Camphor 4.0% w/wMenthol 10.0% w/w

Purpose

Topical Analgesic

Uses:

Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

• For external use only.• Flammable, Keep away from fire or flame.• Avoid getting into eyes or on mucous membranes.• If conditions worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor.

Do Not Use

• on wounds or damaged skin.• Do not bandage tightly.


• Caution: Discontinue use if excessive irritation of the skin develops.

Keep Out Of Reach Of Children.

• Use only as directed.


• Do not use if pregnant or breastfeeding.


• If swallowed, get medical help or contact a poison control center right away.

Directions:

SHAKE WELL BEFORE USE


Adults and children 12 years of age and older: Using the roll-on applicator, massage a liberal amount of gel directly on the affected area not more than 3-4 times daily. Children under 12 years of age: Ask a doctor.

Other Information:

Store between 10 and 30ºC (50-86ºF) Avoid freezing and excessive heat above 32ºC (90ºF)

Inactive Ingredients:

Acrylates/Beheneth- 25 Methacrylate Copolymer,Caprylyl Glycol, Chondroitin Sulfate, Ethanol SDA 40B, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Magnesium Chloride, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Triethanolamine, Water

* Please review the disclaimer below.