Label: GENIUS CARE ANTIBACTERIAL HANDSOAP LEMON- benzalkonium chloride soap

  • 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 September 30, 2020

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  • Active Ingredient(s)

    Benzalconium Choloride 0.13 % Purpose: Antiseptic

  • Purpose

    Antiseptic, Genius Care Antibacterial Hand Soap

  • Uses

    For handwashing to help decrease bacteria on the skin.

  • Warnings

    For external use only.

    Keep away from fire.

    Dont use in or near the eyes.

    in case of contact, rinse eyes thoroughly with water.

    Stop use and ask doctor if irritation or redness devolops.

    Keep out of rich children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness devolops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison Control Center immediately.

  • Directions

    • Pump into hands. wet as needed.
    • Lather vigorously for at least 15 seconds.
    • Wash skin, rinse thoroughly and dry.
    • Children under 6 years of age should be supervised when using.
  • Other information

    • Store between 110 F (43 C).
  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betain, Glycerin, Sodium Chloirde, Cocamide MEA, Lauramine Oxide,

    PEG-120 Methyl Glucose Dioleate, PArfum, Tetrasodium EDTA, Citric Acid, Benzophenone-4, Citrus Limon ( Lemon) Fruit Extract,

    Magnesium Chloride, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, C.I. 19140, C.I. 17200

  • Package Label - Principal Display Panel

    500 mL NDC: 79320-121-01

    500 ml label

  • INGREDIENTS AND APPEARANCE
    GENIUS CARE ANTIBACTERIAL HANDSOAP LEMON 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79320-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W) 1 g  in 1 L
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) 0.7 g  in 1 L
    SULISOBENZONE (UNII: 1W6L629B4K) 0.05 g  in 1 L
    MAGNESIUM NITRATE (UNII: 77CBG3UN78) 0.05 g  in 1 L
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.001 g  in 1 L
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 1 L
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.5 g  in 1 L
    WATER (UNII: 059QF0KO0R)  
    LEMON JUICE (UNII: AGN709ANTJ) 0.1 g  in 1 L
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 4 g  in 1 L
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 0.05 g  in 1 L
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 1.5 g  in 1 L
    COCO MONOETHANOLAMIDE (UNII: C80684146D) 1.5 g  in 1 L
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0004 g  in 1 L
    D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0001 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79320-121-010.5 L in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/30/2020
    Labeler - RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI (520068126)
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