Air Sinsin Pas
FDA Label NDC 55264-011

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 Air Sinsin Pas (NDC 55264-011). 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, do not 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.

Active Ingredients

L-menthol 2.89%

D-camphor 3.61%

Methyl salicylate 3.61%

Purpose

Topical Analgesic

Uses

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

  • arthritis
  • muscular pains
  • strains
  • bruises
  • sprains

Warnings

    For external use only.
  • Avoid inhalation.
  • Do not use in a confined space.
  • Keep away from fire or flame.
  • Contents under pressure.
  • Do not puncture or incinerate container.
  • Do not expose to temperature exceeding 120 degrees F (48 degrees C).

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 times as, other external analegic products.
  • if you are allergic to any ingredients of this product.

When Using This Product

  • do not use otherwise than as directed.
  • avoid contact with the eyes, mucous membranes or rashes.
  • do not bandage tightly.

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.

Directions

Adults and children 12 years of age and over:
  • Clean and dry affected area.
  • Shake the can before use.
  • Spray onto affected area no longer than 3 seconds.
  • Do not use more than 5 times daily for not more than 7 days.
  • Children under 12 years of age:
    • consult a doctor.

Other Information

  • Do not store in direct sunlight.
  • Store in Room Temperature (1 ~ 30 degrees C)

Inactive Ingredients

Diphenhydramine, Thymol, Glycol Salycylate, Liquefied petroleum gas, Perfume, Ethyl alcohol, Anhydrous ethanol

Manufactured By:

SINSIN PHARM. CO., LTD.

776-6, Wonsi-Dong, Danwon-Gu, Ansan City, Kyunggi-Do, Korea

http://www.sinsin.com    tel: 82-2-2152-4860

* Please review the disclaimer below.