Label: PANA HEALTH INSTANT HAND SANITIZER GEL- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 26, 2020

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  • Active Ingredient(s)

    Active ingredientEthyl Alcohol 80% v/v..........................Antiseptic

  • Purpose

    PurposePurpose.Antiseptic

  • Use

    USEHealth care personnel hand rub to help reduce bacteria that potentially can cause disease.

  • Warnings

    Warnings
    For external use only. Flammable. Keep away from heat or flame.

  • Do not use

    do not use■ in children less than 2 months of age

    ■ on open skin wounds

  • When using this product

    When using
    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

    stop useStop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children

    keep out
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions
    ■ Place enough product on hands to cover all surfaces. Rub hands together until dry.
    ■ Supervise children under 6 years of age

  • Other information

    Other
    ■ Store between 15-30°C (59-86°F)
    ■ Avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    Inactive ingredients
    Water, Glycerin, Carbomer, Aminomethyl Propanol, Mentha Arvensis Leaf Oil, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract

  • Package Label - Principal Display Panel

    PDPPANA

    HEALTH

    INSTANT

    HAND SANITIZER

    16.9 fl.oz.(500ml)

  • INGREDIENTS AND APPEARANCE
    PANA HEALTH INSTANT HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73862-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73862-204-1124 in 1 CASE04/30/2020
    1NDC:73862-204-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    Labeler - E.CIS COSMETIC.Co.,Ltd (689846270)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.CIS COSMETIC.Co.,Ltd689846270manufacture(73862-204)
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