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  5. Label Information: Sinsinpas Arex Instant Pain Relief (not For Sale)

FDA Label for Sinsinpas Arex Instant Pain Relief (not For Sale)

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. CAUTION:
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. MANUFACTURED BY:
    14. PRINCIPAL DISPLAY PANEL

Sinsinpas Arex Instant Pain Relief (not For Sale) 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 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg


Purpose



Topical Analgesic


Uses



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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Do Not Use



  • on wounds or damaged skin
  • if you are allergic to aspirin or salicylates
  • with a heating pad
  • with, or at the same time as, other external analgesic products.

Ask A Doctor Before Use



if you are allergic to any ingredients of this product


When Using This Product



  • do not use otherwise than directed.
  • avoid contact with the eyes, mucous membranes or rashes.

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.

Keep Out Of Reach Of Children.



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


Caution:



This product contains natural rubber latex which may cause allergic reactions.


Directions



Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film.
  • Apply to affected area not more than 3 to 4 times daily for 7 days.
  • Remove patch from skin after at most 8 hours application.

    • Children under 12 years of age:

    • Consult a doctor.

Other Information



  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive Ingredients



Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YS Resin.

FDA NDC No.: 55264-020-10


Manufactured By:



SINSIN PHARM. CO., LTD.

90, Beomjigi-ro 141 beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea

tel: 82-31-776-1140~3 http://www.sinsin.com


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