NDC 55264-114 Sinsinpas Arexgel

L-menthol

NDC Product Code 55264-114

NDC 55264-114-02

Package Description: 1 PATCH in 1 POUCH > 6 PATCH in 1 PATCH (55264-114-01)

NDC Product Information

Sinsinpas Arexgel with NDC 55264-114 is a a human over the counter drug product labeled by Sinsin Pharmaceutical Co., Ltd.. The generic name of Sinsinpas Arexgel is l-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: 2568113.

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.

Sinsinpas Arexgel 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.

  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • NONIVAMIDE (UNII: S846B891OR)
  • SORBITOL (UNII: 506T60A25R)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • KAOLIN (UNII: 24H4NWX5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • WATER (UNII: 059QF0KO0R)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • 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: Sinsin Pharmaceutical Co., Ltd.
Labeler Code: 55264
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: 08-27-2021 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.

Sinsinpas Arexgel 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

L-Menthol 76.8mgMethyl Salicylate 57.6mgDL-Camphor 96.0mg

Purpose

Topical Analgesic

Uses

  • For the temporarily relief of minor aches and pains of muscles and joints associated with:Arthritis Simple backache StrainsBruises Sprains

Warnings

  • For external use onlyDo not useon wounds or damaged skinif you are allergic to any ingredients of this productwith a heating padwith, or at the same time as, other external analgesic productsAsk a doctor before use if you are allergic to any ingredients in this product.
  • When using this productdo not use other than directedavoid contact with eyes, mucous membranes, and rashesStop use and ask a doctor ifrash, itching, or excessive skin irritation developscondition worsenssymptoms persist for longer than 7 dayssymptoms clear up and reoccur within a few days
  • If pregnant or breast-feeding, ask a health professional before use.
  • Caution: This product contains natural rubber latex which may cause allergic reactions.

Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Adults and children 12 years of age and over:Clean and dry affected areaRemove patch from filmApply to affected area no more than 3 to 4 times daily for 7 daysRemove patch from skin after at most 8 hours’ applicationChildren undress 12 years of age: consult a doctor

Other Information

  • Avoid storing product in direct sunlightProtect from excessive moisture

Inactive Ingredients

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

* Please review the disclaimer below.