Label: ROYAL HAND SANITIZER- 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 January 9, 2013

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  • Active ingredient

    Ethyl Alcohol 62 percent

  • Purpose

    Antimicrobial

  • Use

    hand sanitizer to help reduce bacteria on the skin that could cause disease.

  • Warnings

    Flammable. Keep away from fire or flame
    For external use only.

  • When using this product

    Do not use in eyes.
    In case of contact with eyes, rinse with water

  • Stop use and ask a doctor if

    irritation and redness develops and persists.

  • Keep out of reach of children

    if swallowed, get medical help promptly.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other information

    Store under 105 degrees F

  • Inactive ingredients

    Water, PEG12-Dimethicone, Carbomer, Fragrance. Aloe Barbadersis Leaf Juice, Triethanolamine.

  • Package label

    ROYAL ALOE Hand Sanitizer

    CAUTION:EYE IRRITANT! MAY BE HARMFUL IF SWALLOWED.
    SEE CAUTION ON BACK PANEL.

    2 fl oz 60ml

    Made in China

    packaging label

  • INGREDIENTS AND APPEARANCE
    ROYAL HAND SANITIZER  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55439-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55439-000-6060 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/07/2013
    Labeler - GPM Investments LLC (132355574)
    Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture(55439-000)
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