Label: SHIELDPLEX- 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 June 12, 2020

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  • Active Ingredient

    0.10% Benzalkonium Chloride

  • PURPOSE

  • Indications

    Eliminates bacteria, sanitizes and moistens hands.

  • Warnings

    For external use only.
    When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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.

  • Directions for use

    Apply lotion on hands and rub vigorously for at least 30 seconds.

  • Inactive ingredients

    Aqua/Eau/Water, Glyceryl Stearate, PEG-100 Stearate, Glycerin , Cetyl alcohol, Caprylic/Capric Triglycerides, lea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil , Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Matricaria recutita (Chamomile) Extract, Lavandula Angustifolia, Ascorbic Acid (Vitamin C), Sodium Polyacrylate, C13-14 Isoparaffin, Laureth-7, Allantoin, Disodium EDTA, Dimethicone, Panthenol, Phenoxyethanol.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    SHIELDPLEX 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75490-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75490-002-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - CLT Logistics Inc. (243174344)
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