Label: AIR SINSIN PAS- camphor, menthol, methyl salicylate aerosol, spray

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 6, 2011

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  • 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

  • Principal Display Panel

    Airpas Display
  • INGREDIENTS AND APPEARANCE
    AIR SINSIN PAS 
    camphor, menthol, methyl salicylate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-011
    Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.361 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.289 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE0.361 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIPHENHYDRAMINE (UNII: 8GTS82S83M)  
    THYMOL (UNII: 3J50XA376E)  
    GLYCOL SALICYLATE (UNII: 3I1VBB7AXH)  
    LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-011-01200 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/01/2011
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture