Label: CHUNG SOL DISINFECTION ETHANOL- ethyl alcohol 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 July 20, 2020

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  • ACTIVE INGREDIENT

    Ethanol 83% v/v

  • INACTIVE INGREDIENT

    Purified water

  • PURPOSE

    ANTISEPTIC

  • WARNINGS

    For external use only.
    ■ Flammable, keep away from heat or flame
    ■ If taken, internally serious gastric disturbances will result
    --------------------------------------------------------------------------------------------------------
    Ask a doctor before use if you have
    ■ Deep or puncture wounds, animal bites or serious burns
    --------------------------------------------------------------------------------------------------------
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    --------------------------------------------------------------------------------------------------------
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    ■ To help prevent the risk of infection in minor cuts, scrapes and burns
    ■ To help reduce bacteria that can cause disease

  • Directions

    ■ Place enough products on hands to cover all surfaces.
    ■ Supervise children under 6years of age when using this product to avoid swallowing.

  • Other information

    ■ Keep away from heat / sparks / open flames / hot surfaces
    ■ Store between 15-30C (59-86F)
    ■ Avoid freezing and excessive heat above 40C (104F)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    CHUNG SOL DISINFECTION ETHANOL 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75765-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL830 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75765-030-011000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - Samhyun pharma (694185214)
    Registrant - Samhyun pharma (694185214)
    Establishment
    NameAddressID/FEIBusiness Operations
    Samhyun pharma694185214manufacture(75765-030)
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