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  5. Label Information: Astrapharm Chilli Brand

FDA Label for Astrapharm Chilli Brand

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. OTC - ASK DOCTOR
    3. KEEP OUT OF REACH OF CHILDREN
    4. DIRECTIONS:
    5. OTHER INFORMATION:
    6. INACTIVE INGREDIENTS:
    7. QUESTIONS OR COMMENTS?
    8. PURPOSE
    9. DO NOT USE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR IF
    12. USES:
    13. WARNINGS
    14. ASTRAPHARM "CHILLI BRAND" EXTERNAL ANALGESIC PLASTER 4.5IN X 7IN
    15. INNER PACKAGE 4.5IN X 7IN
    16. ASTRAPHARM "CHILLI BRAND" EXTERNAL ANALGESIC PLASTER 4.5IN X 3.4IN
    17. INNER PACKAGE 4.5IN X 3.5IN

Astrapharm Chilli Brand Product Label

The following document was submitted to the FDA by the labeler of this product Dersan 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



Capsaicin 0.25%..............................External analgesic


Otc - Ask Doctor



Stop use and ask doctor if


Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions:



  • Clean and dry affected area, peel plaster away from paper backing and apply to the affected area by pressing edges down firmly.
  • If needed, cut plaster into smaller pieces.
  • Adults and children 12 years of age and over: Apply to affected area not more than 3 times daily. Children under 12 years, consult doctor before use.

Other Information:



  • Once opened, keep the unused plaster in an air-tight container.
  • Store at 20-25°C(68-77°F)

Inactive Ingredients:



Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha(petroleum), polybutenes, rubber(natural), synthetic iron oxide, and zinc oxide


Questions Or Comments?



M-F, 9 am to 5 pm Pacific Time

  • You may also report serious side effects to this phone number.


Purpose



External analgesic


Do Not Use



  • on wounds
  • damaged or irritated skin

When Using This Product



  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly
  • may cause rash or festering. Not recommended for people with sensitive skin.
  • burning sensation may occur. Not recommended for use when in contact with hot water.
  • highly adhesive plaster may hurt skin upon removal of product. Do not apply on hairy surface of skin.

Stop Use And Ask A Doctor If



  • Excessive irritation of the skin develops
  • Condition worsens
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • When using for pain of arthritis:
  •    if redness is present
  •    in conditions affecting children under 12 years of age  


Uses:



Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only


Astrapharm "Chilli Brand" External Analgesic Plaster 4.5In X 7In



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Inner Package 4.5In X 7In



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Astrapharm "Chilli Brand" External Analgesic Plaster 4.5In X 3.4In



3.jpg


Inner Package 4.5In X 3.5In



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