Sinsinpas Arexlotion
FDA Label NDC 55264-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sinsin Pharmaceutical Co., Ltd. for the product Sinsinpas Arexlotion (NDC 55264-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Methyl Salicylate 200.0mg

L-Menthol 60.0mg

Tocopherol Acetate 1.0mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

  • Arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises
  • Cramps

Warnings

For external use only

allergy 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 product

  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  • do not use at the same time as other topical analgesics
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
  • avoid applying into skin folds

    • stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

      • 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.

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 area
  • massage into painful area until thoroughly absorbed into skin

    • repeat as necessary, but no more than 3 to 4 times daily

    • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

      • Children undress 12 years of age: ask a doctor

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.