NDC 55264-107 Sinsin Mulpas

L-menthol, Methyl Salicylate, Dl-camphor, Chlorpheniramine Maleate, Thymol

NDC Product Code 55264-107

NDC Code: 55264-107

Proprietary Name: Sinsin Mulpas Additional informationCallout TooltipWhat 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: L-menthol, Methyl Salicylate, Dl-camphor, Chlorpheniramine Maleate, Thymol Additional informationCallout TooltipWhat 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.


Code Structure
  • 55264 - Sinsin Pharmaceutical Co., Ltd.
    • 55264-107 - Sinsin Mulpas

NDC 55264-107-02

Package Description: 1 CONTAINER in 1 BOX > 120 mL in 1 CONTAINER (55264-107-01)

NDC Product Information

Sinsin Mulpas with NDC 55264-107 is a a human over the counter drug product labeled by Sinsin Pharmaceutical Co., Ltd.. The generic name of Sinsin Mulpas is l-menthol, methyl salicylate, dl-camphor, chlorpheniramine maleate, thymol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Sinsin Pharmaceutical Co., Ltd.

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 Additional informationCallout TooltipWhat 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.


Sinsin Mulpas Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAMPHOR (SYNTHETIC) 4500 mg/120mL
  • CHLORPHENIRAMINE MALEATE 100 mg/120mL
  • MENTHOL 4200 mg/120mL
  • METHYL SALICYLATE 6900 mg/120mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • NONIVAMIDE (UNII: S846B891OR)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-11-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Sinsin Mulpas Product Label Images

Sinsin Mulpas 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-mentholMethyl salicylatedl-camphorChlorpheniramine maleateThymol

Purpose

Topical Analgesic

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.

Uses

  • For the temporarily relief of minor aches and pains of muscles and joints associated with:ArthritisSimple backacheStrainsBruisesSprains

Warnings

  • For external use only
  • Do not use
  • On 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 productsWhen using this productdo not use otherwise than directedavoid contact with eyes, mucous membranes or rashesdo not bandage tightlyAsk a doctor before use if you are prone to allergic reaction from aspirin or salicylatesStop use and ask a doctor ifrash, itching, or excessive skin irritation developsconditions worsensymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysIf pregnant or breast-feeding, ask a health professional before use.

Directions

  • Adults and children 2 years of age and over:Apply to affected area no more than 3 to 4 times dailyChildren undress 12 years of age: consult a doctor

Inactive Ingredients

Concentrated glycerin, ethanol, purified water, vanillyl nonylamide.

* Please review the disclaimer below.

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