Label: GENTLE HAND ANTIBACTERIAL EUCALYPTUS MINT- benzalkonium chloride soap

  • NDC Code(s): 73025-065-00
  • Packager: Shalom International Corp
  • 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 July 10, 2020

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

  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • Uses

    • For hand washing to decrease bacteria on the skin.
  • Warnings

    • For external use only

    • When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    • Stop use & ask a doctor

    if irritation or rash appears & lasts.

    • Keep out of reach of children.

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

    • wet hands with water
    • apply palmful to hands and scrub thoroughly 
    • rinse and dry thoroughly
    • intended for repeat use
  • Inactive Ingredients:

    Water (Aqua), Cocamidopropyl Betaine, PEG-150 Distearate, Cocamide MEA, Fragrance (Parfum), Benzyl Alcohol, Phenoxyethanol, Sodium Hydroxide, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Benzoic Acid.

  • Questions?

    • Call 212-391-6970
  • Package Labeling

    Label1

  • INGREDIENTS AND APPEARANCE
    GENTLE HAND ANTIBACTERIAL EUCALYPTUS MINT 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73025-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73025-065-00500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - Shalom International Corp (001384825)