NDC 72800-001 Joint And Muscle Relief 450 Mg

Menthol And Lidocaine

NDC Product Code 72800-001

NDC 72800-001-30

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Joint And Muscle Relief 450 Mg with NDC 72800-001 is a a human over the counter drug product labeled by Lifecure Rx Specialty Pharmacy. The generic name of Joint And Muscle Relief 450 Mg is menthol and lidocaine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Lifecure Rx Specialty Pharmacy

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.

Joint And Muscle Relief 450 Mg 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 30 mg/mL
  • LIDOCAINE 20 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.

  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • CARBOMER 934 (UNII: Z135WT9208)
  • JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
  • HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
  • ALCOHOL (UNII: 3K9958V90M)
  • GERANIUM THUNBERGII FLOWERING TOP (UNII: 9IXM1668B6)
  • HEMP (UNII: TD1MUT01Q7)
  • HORSE CHESTNUT (UNII: 3C18L6RJAZ)
  • LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • 1,2-DILINOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 7L874P1M1O)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Lifecure Rx Specialty Pharmacy
Labeler Code: 72800
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: 03-05-2019 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: 12-31-2020 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.

Joint And Muscle Relief 450 Mg Product Label Images

Joint And Muscle Relief 450 Mg 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

Uses

Temporary relief of minor arthritis, backache, muscle and joint pain

Warnings

For external use onlyAllergy alert: If prone to allergic reaction to latex, consult a doctor before use. Symptoms may include: • rash • blisters • skin reddeningIf a skin reaction occurs, stop use and seek medical help right away.

Directions

• adults and children 12 and older: Apply 1 to 4 pumps to areas of pain and discomfort. Reapply as necessary using no more than 4 times daily.• children under the age of 12: Do not use, ask a doctor

When Using This Product:

• Use only as directed • Avoid contact with eyes and mucous membranes • do not use with a heating pad • do not bandage tightly • do not apply to wounds or damaged skin

Stop And Ask Doctor If

• condition worsens • symptoms last for more than 7 days • symptoms clear up and occur again within a few days • redness or irritation occurs

Storage

• Store at 20-35 deg C (68-77deg F).

Keep Out Of Reach Of Children And Pets

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

Active Ingredients & Purpose

Menthol 3%----------------- AnalgesicLidocaine 2%--------------- Analgesic

Inactive Ingredient

Bergamot oil, carbomer 940, caderwood oil, devil' claw extract, ethanol, geranium oil, Glydant Plus, hemp extract cannabidiol oil, horse chestnut seed extract, lavender oil, oleic acid, propylene glycol, purified water, soya photidylcholine, triethanolamine.

* Please review the disclaimer below.