Label: HAND SANITIZER WIPES- juniper clean cloth

  • 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 November 25, 2022

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  • SPL UNCLASSIFIED SECTION

    SPL UNCLASSIFIED SECTION

  • Active Ingredient(s)

    Benzalkonium Chloride (CAS NO: 68424-85-1), 0.125% .

    Purpose

    Antimicrobial

  • Use

    Hand sanitizing wipes help remove bacteria from hands and kill 99.99% of germs. Removes dirt to help with health and cleanliness.

  • WARNINGS

    Use on hands only.

    Do not use

    If you are allergic to any of the ingredients.

    Stop use and ask a doctor

    if irritation or rash occurs.

    Do not use in or near the eyes.

    If contact occurs rinse with plenty of water. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical advice/attention.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    To Open Package: Flip open dispensing cap. Locate wipe at center of roll and pull through small openning in lid. For best results dispense wipes at an angle. Wet hands thoroughly with product and allow to dry. When finished, snap lid cap shut to retain moisture. Discard wipe in trash receptacle after use. Do not flush.

  • Inactive ingredients

    Water(Aqua), Ethanol, Decyl Glucoside, Glycerine, Aloe Vera Extract, D-Panthenol, Fragrance (Perfume)

  • Package Label - Principal Display Panel

    110 mL NDC: 76557-001-01 110ML

    245 mL NDC: 76557-001-01 245ML

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WIPES 
    juniper clean cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76557-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.125 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE (UNII: K48IKT5321)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76557-001-0475 in 1 CANISTER06/04/2020
    13.14 mg in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:76557-001-0335 in 1 CANISTER06/04/2020
    23.14 mg in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:76557-001-0572 in 1 PACKAGE06/04/2020
    33.14 mg in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/04/2020
    Labeler - KYNC Design LLC (039933298)
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