NDC 55264-112 Sinsinpas Arexlotion

L-menthol

NDC Product Code 55264-112

NDC 55264-112-02

Package Description: 1 BOTTLE in 1 BOX > 1 LOTION in 1 BOTTLE (55264-112-01)

NDC Product Information

Sinsinpas Arexlotion with NDC 55264-112 is a a human over the counter drug product labeled by Sinsin Pharmaceutical Co., Ltd.. The generic name of Sinsinpas Arexlotion is l-menthol. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Arexlotion 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.

  • CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • NONIVAMIDE (UNII: S846B891OR)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • LANOLIN OIL (UNII: OVV5IIJ58F)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CITRUS JUNOS FRUIT (UNII: 53KHW58C1V)

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 Arexlotion 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

Methyl Salicylate 200.0mgL-Menthol 60.0mgTocopherol Acetate 1.0mg

Purpose

Topical Analgesic

Uses

  • Temporarily relieves minor pain associated with:ArthritisSimple backacheMuscle strainsSprainsBruisesCramps

Warnings

  • For external use onlyallergy alert: If prone to allergic reaction from aspirin or salicylates or allergic to any ingredients in this product, consult a doctor before use.When using this productuse only as directedavoid contact with eyes and mucous membranes or rashesrare cases of serious burns have been reported with products of this typedo not apply to wounds or damaged, broken irritated skindo not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of usedo not use at the same time as other topical analgesicsa transient burning sensation may occur upon application but generally disappears in several daysif severe burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlightavoid applying into skin folds
  • Stop use and ask a doctor ifcondition worsensredness is presentirritation developssymptoms persist for more than 7 days or clear up and occur again within a few daysyou experience signs of skin injury, such as pain, swelling, or blistering where the product was appliedIf 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.

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:apply a thin layer to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than 3 to 4 times daily
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATERChildren undress 12 years of age: ask a doctor

Other Information

  • Avoid storing product in direct sunlight, store at 20-25C (68-77F)Store with lid closed tightly

Inactive Ingredients

Nonylic acid vanillyamide, Carbomer 941, Light liquid paraffin, Polysorbate 60, Sorbital Monostearate. Lanolin oil, Triethanolamine, Fresh yuja flavor, Purified water

* Please review the disclaimer below.