Label: ANTIBACTERIAL HAND TROPICAL TWIST- benzalkonium chloride soap

  • NDC Code(s): 41250-754-01
  • Packager: Meijer Distribution Inc.
  • 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 December 21, 2020

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

  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.10%

    Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only, hands 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. Lather vigorously and wash skin. Rinse and dry thoroughly.

  • Inactive Ingredients

    • Water, Cocamidopropyl Betaine, Glycol Propylene, Polyaminoproproyl Biguanide, Fragrance, PEG-150 Distearate, Olive Oil PEG-7 Esters, Disodium EDTA, Citric Acid, FD&C Blue No.1, D&C Red No.33.

  • Questions?

    • Call 212-391-6970

  • Package Labeling:

    295 ml

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND TROPICAL TWIST 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-754
    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
    PEG-7 STEARATE (UNII: VCX261B12R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-754-01295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/30/2020
    Labeler - Meijer Distribution Inc. (006959555)