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  5. Label Information: Sinsinpas Hot Large

FDA Label for Sinsinpas Hot Large

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. DISTRIBUTED BY:
    10. PRINCIPAL DISPLAY PANEL

Sinsinpas Hot Large 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



Capsicum extract 0.025% as Capsaicin


Purpose



Topical Analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings



For external use only



Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

    • When using this product

    • do not use otherwise than directed
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower

      • 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.

        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:

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

    • Children under 12 years of age: consult a doctor


Inactive Ingredients



butyl hydroxytoluene, glyceryl rosinate, isopropryl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (YS resin), titanium oxide, zinc oxide


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