Label: ROYAL-PLANT HAND SANITIZER- benzalkonium chloride liquid

  • 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 April 11, 2020

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  • Active ingredient

    Benzalkonium Chloride (0.13%)

  • Purpose

    Antibacterial

  • Uses

    Hand sanitizer for decreasing bacteria on skin

  • Warnings

    For external use only

    Do not use if you are allergic to any of the ingredients

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.

    Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours

    If pregnant or breast- feeding, ask a health professional before use.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Take appropriate amount onto your hand and spread it all the way to fingertips. Rub the contents until it dries.

  • Inactive ingredient

    Water, Ozone, Oxydants, Sodium Hypochlorite, Chlorine Dioxide, Sodium Chlorate

  • Royal-Plant Sanitizer

    royal plant hand sanitizer

  • INGREDIENTS AND APPEARANCE
    ROYAL-PLANT HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74606-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORATE (UNII: T95DR77GMR)  
    OZONE (UNII: 66H7ZZK23N)  
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74606-100-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/11/2020
    Labeler - Dor Properties LLC. (057666728)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dor Properties LLC.057666728manufacture(74606-100)
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