Sinsinpas Hot Large
FDA Label NDC 55264-110

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 Hot Large (NDC 55264-110). 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

Capsicum extract 0.025% as Capsaicin

Purpose

Topical Analgesic

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

For external use only



Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

    • When using this product

    • do not use otherwise than directed
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower

      • 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

        • 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

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

    • Children under 12 years of age: consult a doctor

Inactive Ingredients

butyl hydroxytoluene, glyceryl rosinate, isopropryl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (YS resin), titanium oxide, zinc oxide

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