NDC 73557-138 Menthol Pain Relief Gel-patch

Menthol

NDC Product Code 73557-138

NDC CODE: 73557-138

Proprietary Name: Menthol Pain Relief Gel-patch 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: 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.

Product Characteristics

Color(s):
BROWN (C48332)

NDC Code Structure

  • 73557 - Shanghai Chuangshi Medical Technology (group) Co., Ltd.

NDC 73557-138-05

Package Description: 5 PATCH in 1 BOX > 5 g in 1 PATCH (73557-138-01)

NDC Product Information

Menthol Pain Relief Gel-patch with NDC 73557-138 is a a human over the counter drug product labeled by Shanghai Chuangshi Medical Technology (group) Co., Ltd.. The generic name of Menthol Pain Relief Gel-patch is menthol. 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 Pain Relief Gel-patch 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.

  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • KAOLIN (UNII: 24H4NWX5CO)
  • TARTARIC ACID (UNII: W4888I119H)
  • WATER (UNII: 059QF0KO0R)
  • DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • LAURALKONIUM CHLORIDE (UNII: 07HUP5A29X)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POVIDONE K30 (UNII: U725QWY32X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: Shanghai Chuangshi Medical Technology (group) Co., Ltd.
Labeler Code: 73557
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: 08-25-2021 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.

Menthol Pain Relief Gel-patch Product Label Images

Menthol Pain Relief Gel-patch 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 Ingredient

Menthol 5.6% ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic

Uses

  • Temporary relief from minor aches and pains of sore muscles and joints associated with:arthritsbackachestrainssprains

Warnings

  • For external use onlyUse only as directedDo not bandage tightly or use with heating pad or deviceAvoid contact with eyes or mucous membranesDo not apply to wounds or damaged skinDo not use with other ointments, creams, sprays, or linimentsDo not apply to irritated skin

Ask Doctor

Ask a doctor before use if you have: Sensitive skin
Stop use and ask a doctor if: Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
If pregnant or breast-feeding: Ask a health professional before use

When Using

  • For external use onlyUse only as directedDo not bandage tightly or use with heating pad or deviceAvoid contact with eyes or mucous membranesDo not apply to wounds or damaged skinDo not use with other ointments, creams, sprays, or linimentsDo not apply to irritated skin

Do Not Use

  • Use only as directedDo not bandage tightly or use with heating pad or deviceAvoid contact with eyes or mucous membranesDo not apply to wounds or damaged skinDo not use with other ointments, creams, sprays, or linimentsDo not apply to irritated skin

Stop Use

Stop use and ask a doctor if: Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Pregnancy Or Breast Feeding

If pregnant or breast-feeding: Ask a health professional before use

Keep Out Of Reach Of Children

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions

  • Adult and Children 12 years of age and older: Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.
  • Children under 12 years of age: Consult physician

Dosage Forms & Strengths

This is patch dosage form.The active ingredient strength is 5%.

Inactive Ingredients

Water, Glycerin, Polyacrylic acid, Propylene glycol, Sodium polyacrylate, Mineral oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum aminoacetate, Edetate disodium, Kaolin, Carboxymethylcellulose sodium, Titanium dioxide,

L-Tartaric acid, Benzalkonium chloride, Lauralkonium chloride, Aloe barbadensis leaf extract, Arnica montana flower extract, Boswellia carterii resin extract, Camellia sinensis leaf extract

Questions

Questions or comments: 86-21-31166566

Other Information

  • Store in a cool dry place away from direct sunlight

* Please review the disclaimer below.