NDC 55301-912 Maximum Strength Lidocaine Plus Menthol

Lidocaine, Menthol

NDC Product Code 55301-912

NDC Code: 55301-912

Proprietary Name: Maximum Strength Lidocaine Plus Menthol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine, Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 55301 - Army And Air Force Exchange Service
    • 55301-912 - Maximum Strength Lidocaine Plus Menthol

NDC 55301-912-05

Package Description: 5 PATCH in 1 POUCH > 8 g in 1 PATCH

NDC Product Information

Maximum Strength Lidocaine Plus Menthol with NDC 55301-912 is a a human over the counter drug product labeled by Army And Air Force Exchange Service. The generic name of Maximum Strength Lidocaine Plus Menthol is lidocaine, menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Army And Air Force Exchange Service

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.

Maximum Strength Lidocaine Plus 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 4 g/100g
  • MENTHOL, UNSPECIFIED FORM 1 g/100g

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.

  • DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • 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: Army And Air Force Exchange Service
Labeler Code: 55301
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: 06-01-2019 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.

Maximum Strength Lidocaine Plus Menthol Product Label Images

Maximum Strength Lidocaine Plus 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

Otc - Active Ingredient

Lidocaine 4% Topical AnestheticMenthol 1% Topical Anesthetic

Otc - Purpose

Topical Anesthetic

Uses

Temporary relief of minor pain

Warnings

  • For External use only. Use only as directed.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Do Not Use

■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened.

If Pregnant Or Breast Feeding

  • Contact a physician prior to use.

When Using:

■ Use only as directed■ Read and follow all directions and warnings on this carton■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still containthe drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use And Consult A Doctor If

■ Condition worsens ■ Redness is present ■ Irritation develops■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Directions Adults And Children 12 Years Of Age And Over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky sideof patch to affected area. Use one patch for up to 12 hours. Discard after single use.Children under 12 years of age: consult a physician.

Inactive Ingredients

Aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Storage And Handling

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Lidocaine + Menthol Patch

TOLL-FREECustomer Care Help Line866-326-1313Mon–Fri 8:30 am–4:30 pm CSTManufactured for Your Military Exchangers ByVeridian HealthcareGurnee, IL 60031

* Please review the disclaimer below.

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