Label: LE K - IMMUNI-T LEMON LIME- benzalkonium chloride lotion

  • NDC Code(s): 82822-100-01
  • Packager: HCD ANTI AGING LABORATORIES LLC
  • 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 5, 2022

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  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.1%

  • PURPOSE

    Benzalkonium chloride 0.1%………………….….…………………………………………………………Antibacterial

  • INDICATIONS & USAGE

    To decrease bacteria on the skin.

  • DOSAGE & ADMINISTRATION

    Apply product on hands as needed. Rub hands together until absorbed.

  • WARNINGS

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

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

  • WHEN USING

    Avoid contact with the eyes.
    Do not apply to wounds or damaged skin.

    Do not apply to the irritated skin or if excessive irritation develops.

  • INACTIVE INGREDIENT

    Aqua, Paraffinum Liquidum, Stearic Acid, Cetyl Alcohol, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Glycereth-26, Dimethicone, Glycol Stearate, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Sodium Hydroxide, Stearyl Alcohol, Parfum, Titanium Dioxide, Zinc Oxide, PEG-25 Hydrogenated Castor Oil, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Pyridoxine Hydrochloride, Tocopheryl Acetate, Zea Mays (Corn) Oil, FD&C Yellow #6 (CI 15985), FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Citral, Limonene, Geraniol, Linalool, Citronellol.

  • PRINCIPAL DISPLAY PANEL

    HCD- IMMUNI-T LEMON LIME ANTI-BACTERIAL LOTION

  • INGREDIENTS AND APPEARANCE
    LE K - IMMUNI-T  LEMON LIME
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82822-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    CORN OIL (UNII: 8470G57WFM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    GERANIAL (UNII: 758ZMW724E)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GERANIOL (UNII: L837108USY)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82822-100-0125 g in 1 POUCH; Type 0: Not a Combination Product07/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2022
    Labeler - HCD ANTI AGING LABORATORIES LLC (118675977)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(82822-100)
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