Label: AROMA GURU ANTIBACTERIAL TOASTED VANILLA- antibacterial hand soap 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 August 31, 2022

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

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.3%

    PRODUCT LABEL

  • PURPOSE

    Antibacterial

  • WARNINGS

    For External Use Only

  • WHEN USING

    When using this product- Avoid contact with eyes. In case of eye contact, flush with water.

  • STOP USE

    Stop Use and ask Doctor if irritation or redness develops

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Pump in hands , wet as needed- Lather vigorously for at least 15 seconds- Wash skin thoroughly and dry.

  • OTHER SAFETY INFORMATION

    Store below 110° F (43° C)

  • INACTIVE INGREDIENT

    Water, Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Sodium Lauroamphoacetate, Phenoxyethanol, Fragrance, DMDM Hydantoin, Disodium EDTA, Benzophenone-4, Citric Acid, CI 19140

  • INDICATIONS & USAGE

    For hand washing to decrease bacteria on the skin

  • PRINCIPAL DISPLAY PANEL

    PRODUCT DISPLAY

  • INGREDIENTS AND APPEARANCE
    AROMA GURU ANTIBACTERIAL  TOASTED VANILLA
    antibacterial hand soap liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70708-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 85.37 g  in 100 g
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 8 g  in 100 g
    Product Characteristics
    Coloryellow (Clear Liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70708-063-01384.45 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/05/2020
    Labeler - GURUNANDA LLC (079671169)