Label: MIRACLE WIPES FOR HAND SANITIZING- benzalkonium chloride 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 February 11, 2021

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in the eyes
  • WHEN USING

    When using this product do not get into eyes. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

  • 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

    • Wet hands thoroughly with product and allow to dry.
    • Children under six years of age should be surprised when using this product.
  • Other information

    • Store in a cool, dry place.
  • Inactive ingredients

    Water, Cocamidopropyl Betaine, Cetrimonium Chloride, Didecyldimonium Chloride, Allantoin, Fragrance, Aloe, Cocamidopropylamine Oxide, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Triethonalamine, Vitamin E, Citric Acid

  • Package Label - Principal Display Panel

    70 Wet Wipes 1 Ply NDC: 79779-002-7070 Wet Wipes 1 Ply NDC: 79779-002-70

  • INGREDIENTS AND APPEARANCE
    MIRACLE WIPES FOR HAND SANITIZING 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79779-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE (UNII: V5VD430YW9)  
    CITRAL (UNII: T7EU0O9VPP)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ORANGE TERPENES (UNII: 9J3RG7FX7S)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALLANTOIN (UNII: 344S277G0Z)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79779-002-7070 g in 1 CANISTER; Type 0: Not a Combination Product03/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/12/2021
    Labeler - Kelly Products, Inc. (117590333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kelly Products, Inc.117590333manufacture(79779-002)
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