Sinsinpas Arexgel
FDA Label NDC 55264-114

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 Arexgel (NDC 55264-114). 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

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Purpose

Topical Analgesic

Uses

For the temporarily 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 any ingredients of this product
  • 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.

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

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 for 7 days
  • Remove patch from skin after at most 8 hours’ application

    • Children undress 12 years of age: consult a doctor

Inactive Ingredients

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

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