Sinsinpas Cold
FDA Label NDC 55264-104

7 label sections · Submitted to the FDA by Sinsin Pharmaceutical Co., Ltd. · 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 Cold (NDC 55264-104). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, sinsinpas cold patch, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

L-Menthol (5%)

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:

  • Arthritis 
  • Simple backache 
  • Strains
  • Bruises 
  • Sprains

Warnings

For external use only


Do not use

  • on wounds or damaged skin
  • if you are allergic to any ingredients of this product
  • with a heating pad
  • with, or at the same time as, other external analgesic products

    • When using this product

    • do not use otherwise than directed
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly

      • Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

      Stop use and ask a doctor if

      • rash, itching, or excessive skin irritation develops
      • conditions worsen
      • symptoms persist for more than 7 days
      • symptoms clear up and occur again within a few days

        • If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area no more than 3 to 4 times daily for 7 days
  • Remove patch from skin after at most 8 hours’ application

    • Children undress 12 years of age: consult a doctor

Inactive Ingredients

Aloe vera gel, BHT, Castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydoxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methyl paraben, PEG monostearte, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate.

* Please review the disclaimer below.