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  5. Label Information: Sinsinpas Cold

FDA Label for Sinsinpas Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. SINSINPAS PAIN RELIEVING PATCH

Sinsinpas Cold 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



DL-Camphor (1.21%)

L-Menthol (5.54%)

Methyl Salicylate (6.11%)


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



Butylated Hydroxytoluene, Ester Gum, Natural Rubber, Polybutene, Polyisobutylene, Precipitated Calcium Carbonate, Quintone, Sorbitan Stearate, Tocopherol Acetate, YS Resin, Zinc Oxide


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