NDC 72784-342 Saint External Pain Relieving Bandage

Menthol

NDC Product Code 72784-342

NDC 72784-342-98

Package Description: 1 PATCH in 1 BAG

NDC Product Information

Saint External Pain Relieving Bandage with NDC 72784-342 is a a human over the counter drug product labeled by Saint Medecine, Inc. The generic name of Saint External Pain Relieving Bandage is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Saint Medecine, Inc

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.

Saint External Pain Relieving Bandage 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, UNSPECIFIED FORM 400 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.

  • PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
  • EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)
  • SAFFLOWER SEED (UNII: 8FCL6A31TX)
  • PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
  • SCHISANDRA CHINENSIS SEED (UNII: MO9DK65G18)
  • CODONOPSIS PILOSULA WHOLE (UNII: 76AI4Q0335)
  • TURMERIC (UNII: 856YO1Z64F)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • METHYL ACRYLATE (UNII: WC487PR91H)
  • ETHYL ACRYLATE (UNII: 71E6178C9T)
  • COTTON FIBER (UNII: 70LDW53ROO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Saint Medecine, Inc
Labeler Code: 72784
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: 03-01-2019 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.

Saint External Pain Relieving Bandage Product Label Images

Saint External Pain Relieving Bandage 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

Menthol 400mg / patch 400mg

Purpose

Topical anesthetic

Uses

Temporary relief minor aches and pains of muscles and joints associated with: •Arthritis •Bruises  •Backache  •Strains  •Sprains  •Legs

Warnings:

For external use onlyWhen using this product:• Use only as directed• Avoid contact with eyes, or mucous membranes• Do not apply to broken, wounded or damaged skin• Do not bandage or cover with any type of wrap except clothing• Do not use with a heating pad or apply external heatStop use or ask a doctor if:• Rash, excessive itching or excessive skin irritation develops• Condition worsens or does not improve after regular useIf pregnant or breast-feeding, ask a professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

  • Adult and children 12 years of age and over • Clean and dry affected area • Open pouch and remove patch, peel off protective backing, then apply sticky side to affected area. Use one patch a day, continue to use until the symptoms are completely gone.Wash hands with soap after applying patchChildren under 12 years of age • Consult a doctor before use

Other Information:

• This product may cause allergic reaction in some individuals.• Store in cool dry place from direct sunlight.

Inactive Ingredients:

Paeonia lactiflora root, Eucommia Ulmoidea bark, Carthamus tinctorius seed, Panax notoginseng root, Magnolia vine, Codonopsis pilosula whole, Curcumae longae rhizoma and Peppermint (Mentha×  piperita) leaf, Methyl acrylate, Ethyl acrylate, Cotton fiber, Methylparaben, Propylparaben (preservatives)

* Please review the disclaimer below.

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