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  5. Label Information: Sinsinpas Arex Instant Pain Relief Small

FDA Label for Sinsinpas Arex Instant Pain Relief Small

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 Arex Instant Pain Relief Small 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 34.10mg

L-Menthol 90.90mg

Mentha Oil 45.46mg

Methyl Salicylate 90.90mg

Zinc Oxide 431.82mg


Purpose



Topical Analgesic


Uses



For temporary 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 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 in this product.

    When using this product

    • Do not use other than directed
    • Avoid contact with eyes, mucous membranes, and rashes

      • Stop use and ask a doctor if

      • Rash, itching, or excessive skin irritation develops
      • Condition worsens
      • Symptoms persist for longer than 7 days
      • Symptoms clear up and reoccur 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.

        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.: 55264-021-06


Distributed By:



SINSIN PHARM AMERICA

Brea, CA 92821

www.sinsinpas.us


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