Label: BENZALKONIUM CHLORIDE MODESS BASICS- antibacterial wash liquid

  • 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 August 25, 2021

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    for incontinent care wash to quickly emulsify body waste even in the most sensitive perineal areas. Enriched with Aloe to help soothe and promote healing of fragile irritated skin. pH balance and helps eliminate odor

  • WARNINGS

    Warning - For external use only

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if

    • irritaion or redness develops
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Spray wash where urine, feces or emesis has soiled skin, pad, linens, and clothing. Remove bulk of feces or emesis.

    Spray additional wash on a warm wet cloth.

    cleanse the skin of all remaining residue

    Note: If the area needing care is sizable and fecal or emesis material massive- rinsing is advised.

    add one capful to the regular laundry to eliminate residual odors.

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl betaine, aloe vera leaf, Vit E, Vit D, Vit A, Allantoin, Citric acid, Methylchloroisothiazolinone and Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE  MODESS BASICS
    antibacterial wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-080
    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)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-080-35354 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2021
    Labeler - Click Products LLC (080766174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corp243748238manufacture(71611-080)
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