Label: HYPERCLN SANITIZING WIPES- anti-microbial wipe 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 October 27, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Anti-bacterial

  • Warning

    For external use only.

    When using this product avoid contact with eyes. If in eyes, flush thoroughly with water.

  • Ask a doctor

    Stop and ask a doctor if:

    :• irritation develops. • condition persists for more than 72 hours.

  • Keep out of the reach of children.

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

  • Dosage and Administration

    Directions (for 40 ct flow pack)

    • Pull one sheet from pack

    • Clean hands or affected area and discard

    • Close pack after each use to keep wipes fresh

  • Inactive ingredients

    Water, Decyl Glucoside, Glycerin, Sodium hydroxymethylglycinate, Citric Acid, PEG-12 Dimethicone, Fragrance, Sodium Benzoate, Potassium Sorbate, Allantoin, Tocopheryl Acetate, Aloe Barbadensis Leaf Water, Chamomilla Recutita (Matricaria) Flower Water, Panthenol, Tetrasodium EDTA, Benzyl Alcohol, Sodium Hydroxide

  • Use

    Hand sanitizer to help reduce bacteria on skin.

  • Primary Displaly Panel

    Hypercln Sanitary Wipes 40

  • INGREDIENTS AND APPEARANCE
    HYPERCLN SANITIZING WIPES 
    anti-microbial wipe cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78847-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHAMOMILE (UNII: FGL3685T2X)  
    TETRAHYDROLINALOOL (UNII: UM4XS5M134)  
    CITRONITRILE (UNII: MS598KEL3M)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    3,7-DIMETHYL-1-OCTANOL (UNII: DPY9K1927C)  
    3,3'-DIHYDROXYDIPROPYL ETHER (UNII: S1OQ81LMNA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78847-320-400.0052 g in 1 PACKAGE; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/13/2020
    Labeler - Falcon Safety Products, Inc. (150582500)
    Registrant - Dan Mor (514523067)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dan Mor514523067manufacture(78847-320)
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