Label: HAND SANITIZER ALCOHOL FREE WITH COCONUT OIL SHEA BUTTER- benzalkonium chloride lotion

  • 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 May 23, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    ■ Hand sanitizing lotion to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

  • When using this product

    ■ keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

  • Stop use and ask a doctor if

    irritation and redness develops and persists.

  • Keep out of reach of children

    If swallowed, contact a doctor or Poison Control Center right away.

  • Directions

    ■ Apply a dime-sized amount onto hands and rub together until absorbed. ■ Supervise children under 6 years of age when using this product

  • Inactive ingredients

    Water, Mineral Oil, Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-25, PEG-100 Stearate, Urea, Dimethicone, Shea (Butyrospermum Parkii) Butter, Phenoxyethanol, Xanthan Gum, Coconut (Cocos Nucifera) Seed Oil, Chlorphenesin, Sodium Hyaluronate

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  ALCOHOL FREE WITH COCONUT OIL SHEA BUTTER
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76383-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARETH-25 (UNII: 36ALR4705B)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76383-030-03100 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/28/2020
    Labeler - BBC GROUP LIMITED (421270060)
    Establishment
    NameAddressID/FEIBusiness Operations
    BBC GROUP LIMITED421270060manufacture(76383-030)
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