Sinsinpas Arex Instant Pain Relief Small
FDA Label NDC 55264-109

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sinsin Pharmaceutical Co., Ltd. for the product Sinsinpas Arex Instant Pain Relief Small (NDC 55264-109). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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