Label: ANTIBACTERIAL MODESS BASICS- benzalkonium chloride 0.13% cream

  • 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 22, 2021

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    -to relieve irritated and dry skin

    -helps soothe and protect skin tissue

    -helps reduce common germs that can cause painful rashes

    -use as a massage cream for immobile patients to help improve circulation

  • Warnings For external use only

    Avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

    condition worsens

    symptoms last more than 7 days or clear up and occur again within a few days

  • When using this product

    Avoid contact with eyes.In case of contact, flush and rinse with water.

    Remove contact lenses, if present and easy to do. Continue rinsing.

  • Keep out of reach of children

    Except under adult supervision. DO NOT EAT DRINK.

    Keep away from food,drink and animal feeding stuffs,

    If swallowed get medical help or contact posion control right away.

  • Directions

    apply small amount to skin and rub in gently, apply as needed

  • INACTIVE INGREDIENT

    Water, cetearyl alcohol, stearic acid, glyceryl stearate, PEG-40 hydrogenated castor oil, mineral oil, glycerin, carbomer, sodium hydroxide, aloe vera leaf extract, tocopheryl acetate, Vitamin A, Vitamin D, allantoin, DMDM hydantoin

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  MODESS BASICS
    benzalkonium chloride 0.13% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-079
    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
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A (UNII: 81G40H8B0T)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-079-14141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/22/2021
    Labeler - CLICK PRODUCTS LLC (080766174)
    Registrant - CLICK PRODUCTS LLC (080766174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corporation243748238manufacture(71611-079)
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