Arex Sinsin Pas Patch
FDA Label NDC 55264-020

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 Arex Sinsin Pas (NDC 55264-020). 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, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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