Label: ROYAL HAND SANITIZER  - alcohol gel 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Ethyl Alcohol 62 percent

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  • Purpose

    Antimicrobial

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  • Use

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

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  • Warnings

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

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  • When using this product

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

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  • Stop use and ask a doctor if

    irritation and redness develops and persists.

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  • Keep out of reach of children

    if swallowed, get medical help promptly.

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  • Directions

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

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  • Other information

    Store under 105 degrees F

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  • Inactive ingredients

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ROYAL HAND SANITIZER  
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55439-000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 620 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALOE VERA LEAF  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55439-000-60 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/07/2013
    Labeler - GPM Investments LLC (132355574)
    Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    Name Address ID/FEI Business Operations
    Shanghai Kejing Cleaning Products Co., Ltd. 526877847 manufacture(55439-000)
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