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  5. Label Information: Sinsinpap Cool

FDA Label for Sinsinpap Cool

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT:
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. STORAGE CONDITION
    10. INACTIVE INGREDIENTS
    11. MANUFACTURED BY:

Sinsinpap Cool Product Label

The following document was submitted to the FDA by the labeler of this product Sinsin Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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