Sinsinpap Cool Patch
FDA Label NDC 55264-012

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 Sinsinpap Cool (NDC 55264-012). 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, when using this product:, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

L-Menthol 49.4 mg

Thymol 16.5 mg

DL-Camphor 82.4 mg

Mentha Oil 164.7 mg

Eucalyptus Oil 16.5 mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with

  • muscular pain
  • joint pain
  • backache
  • bruise
  • sprain

Warnings

For external use only

When Using This Product:

  • use only as directed
  • do not bandage tightly or use with a healing pad
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop Use And Ask A Doctor If

  • conditions worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

Keep Out Of Reach Of Children.

If swallowed, get medical help from hospital right away

Directions

  • Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: do not use, consult a doctor
  • For easy application: partially peel back protective film and apply exposed patch to the site of pain.
  • Carefully remove remaining film while pressing patch to skin for secure adhesion.

Storage Condition

  • avoid storing product in direct sunlight
  • store at room temperature

Inactive Ingredients

BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water

Manufactured By:

SINSIN PHARM. CO., LTD.

Distributed by SS Pharmed USA

Made in Korea

NDC # : 55264-012-01

* Please review the disclaimer below.