Sinsinpas Arex Instant Pain Relief Small

Camphor, Menthol, Mentha Oil, Methyl Salicylate, Zinc Oxide

Sinsin Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 55264-109

Sinsinpas Arex Instant Pain Relief Small also known as Camphor, Menthol, Mentha Oil, Methyl Salicylate, Zinc Oxide is a human otc drug labeled by 'Sinsin Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Sinsinpas Arex Instant Pain Relief Small is 55264-109. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Sinsinpas Arex Instant Pain Relief Small drug includes Camphor (synthetic) - 34.1 mg/1 Levomenthol - 90.9 mg/1 Methyl Salicylate - 90.9 mg/1 Peppermint Oil - 45.46 mg/1 Zinc Oxide - 431.82 mg/1 . The currest status of Sinsinpas Arex Instant Pain Relief Small drug is Active.

Drug Information:

Drug NDC:	55264-109
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Sinsinpas Arex Instant Pain Relief Small
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Camphor, Menthol, Mentha Oil, Methyl Salicylate, Zinc Oxide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Sinsin Pharmaceutical Co., Ltd.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Patch
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CAMPHOR (SYNTHETIC) - 34.1 mg/1 LEVOMENTHOL - 90.9 mg/1 METHYL SALICYLATE - 90.9 mg/1 PEPPERMINT OIL - 45.46 mg/1 ZINC OXIDE - 431.82 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	CUTANEOUS TOPICAL TRANSDERMAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	29 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part348
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Sinsin Pharmaceutical Co., Ltd.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0685522000198
UPC stands for Universal Product Code.
UNII:	5TJD82A1ET BZ1R15MTK7 LAV5U5022Y AV092KU4JH SOI2LOH54Z
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
55264-109-01	1 PATCH in 1 POUCH (55264-109-01) / 10 PATCH in 1 PATCH	29 Jun, 2021	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Sinsinpas Arex Instant Pain Relief Small

Camphor, Menthol, Mentha Oil, Methyl Salicylate, Zinc Oxide

Patch
Sinsin Pharmaceutical Co., Ltd.
NDC: 55264-109

Purpose:

Purpose topical analgesic

Product Elements:

Sinsinpas arex instant pain relief small camphor, menthol, mentha oil, methyl salicylate, zinc oxide benzyl nicotinamide butylated hydroxytoluene calcium carbonate glycerin rosin natural latex rubber polyisobutylene (200000 mw) polybutene (1400 mw) nonivamide camphor (synthetic) camphor (synthetic) peppermint oil peppermint levomenthol levomenthol methyl salicylate salicylic acid zinc oxide zinc oxide

Indications and Usage:

Uses for temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sprains

Warnings:

Warnings for external use only do not use on wounds or damaged skin if you are allergic to aspirin or salicylates with a heating pad with, or at the same time as other external analgesic products ask a doctor before use if you are allergic to any ingredients in this product. when using this product do not use other than directed avoid contact with eyes, mucous membranes, and rashes stop use and ask a doctor if rash, itching, or excessive skin irritation develops condition worsens symptoms persist for longer than 7 days symptoms clear up and reoccur within a few days if pregnant or breast-feeding, ask a health professional before use keep out of reach of children if swallowed, get medical help or contact a poison control center right away. caution this product contains natural rubber latex which may cause allergic reactions.

Dosage and Administration:

Directions adults and children 12 years of age and over: clean and dry affected area remove patch from film. apply to affected area not more than 3 to 4 times daily for 7 days. remove patch from skin after at most 8 hours application. children under 12 years of age: consult a doctor.

Package Label Principal Display Panel:

Principal display panel sinsinpas arex small

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.