NDC 70645-701 Lidocaine And Menthol

Lidocaine And Menthol

NDC Product Code 70645-701

NDC 70645-701-15

Package Description: 15 PATCH in 1 BOX

NDC Product Information

Lidocaine And Menthol with NDC 70645-701 is a a human over the counter drug product labeled by 7t Pharma Llc. The generic name of Lidocaine And Menthol is lidocaine and menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: 7t Pharma 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 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.

Lidocaine And Menthol 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.

  • LIDOCAINE 40 mg/1
  • MENTHOL 40 mg/1

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • LEMON OIL (UNII: I9GRO824LL)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

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: 7t Pharma Llc
Labeler Code: 70645
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.

Lidocaine And Menthol 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

Purpose

Lidocaine 4%..................................................................................................Topical AnestheticMenthol 4%.....................................................................................................Topical Analgesic

Uses

Temporarily relieves minor aches and muscle pains associated with: • arthritis• simple backache• strains• muscle soreness• muscle stiffness

Warnings

For external use only. Read all warnings and directions before use.

Do Not Use

• More than one patch at a time.• On wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.• With a heating pad or cover with bandage. • If you are allergic to any ingredients of this productAllergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

When Using This Product

• Use only as directed. • Avoid contact with eyes, mucous membranes, or rashes• Do not tightly wrap or bandage the treated area

Stop Use And Ask A Physician:

• If pregnant or breast feeding • If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Keep Out Of Reach Of Children And Pets.

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

Directions

Adults and children 12 years of age and older:Apply 1 patch to the affected area of intact skin 1 to 2 times daily or as directed. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area.- Open pouch and remove one patch.- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches.- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 12 years: Ask a physician

Other Information

Store at room temperature 15°-30°C (59°-86°F)Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

Aqua (Deionized Water), Glycerine, Sodium Polyacrylate, Polysorbate 80, EDTA Disodium salt, Methylparaben, Citrus Medica Limonum (Lemon) Peel Oil, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Propylparaben

* Please review the disclaimer below.