NDC 71391-123 Menthol 5%

Menthol, Unspecified Form

NDC Product Code 71391-123

NDC 71391-123-18

Package Description: 18 POUCH in 1 BOX > 1 PATCH in 1 POUCH

NDC 71391-123-36

Package Description: 36 POUCH in 1 BOX > 1 PATCH in 1 POUCH

NDC Product Information

Menthol 5% with NDC 71391-123 is a a human over the counter drug product labeled by Unexo Life Sciences, Private Limited. The generic name of Menthol 5% is menthol, unspecified form. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 420222.

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.

Menthol 5% 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.


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.

  • ALOE (UNII: V5VD430YW9)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • LANOLIN (UNII: 7EV65EAW6H)
  • SPEARMINT (UNII: J7I2T6IV1N)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

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: Unexo Life Sciences, Private Limited
Labeler Code: 71391
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: 03-01-2018 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".

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Menthol 5% 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

Other

Drug Facts

Manufactured By:UNEXO LIFE SCIENCES PVT. LTD.B-16. Sector 4, Bawana Industrial Area,Delhi – 110039 (INDIA)

Otc - Purpose

Menthol 5% - Topical Analgesic

Uses

  • For temporary relief of minor aches and pains of muscles and joints associated with:Simple backache ArthritisSprainsStrainsBruises

Warnings

For external use only

Do Not Use

  • On wounds or damaged skin With a heating pad

Ask A Doctor Before Use If You Have

  • Redness over affected area

When Using This Product

  • Avoid contact with eyes and mucous membranesDo not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few daysExcessive skin irritation occurs

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.

Directions

  • Adults and children 12 years of age and older apply to the affected area no more than 3 to 4 times dailyOpen pouch & remove patchPeel off protective film and apply sticky side to affected areaChildren under 12 years of age consult a doctor

Inactive Ingredients

Adhesive plaster, aloe extract, dl-camphor, purified lanolin, spearmint, titanium dioxide, zinc oxide

Questions

Call 1-215-666-3200

* Please review the disclaimer below.