Label: HYPERCLN SANITARY WIPES- anti-microbial 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 July 14, 2020

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  • Active Ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Anti-bacterial

  • Warning

    Warnings

    For external use only.

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

  • Stop and 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.

  • Inactive ingredients

    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

  • Indications

    Hand sanitizer to help reduce bacteria on skin.

  • Directions

    To Use: open, unfold and apply. Sanitize hands or other affected area. Discard in trash after use. Do not flush.

  • Principal display panel

    Hypercln Sanitary Wipes 75

  • INGREDIENTS AND APPEARANCE
    HYPERCLN SANITARY WIPES 
    anti-microbial cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78847-321
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTOL (UNII: RV6J6604TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CITRONITRILE (UNII: MS598KEL3M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    WATER (UNII: 059QF0KO0R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    3,7-DIMETHYL-1-OCTANOL (UNII: DPY9K1927C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    3,3'-DIHYDROXYDIPROPYL ETHER (UNII: S1OQ81LMNA)  
    TETRAHYDROLINALOOL (UNII: UM4XS5M134)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78847-321-7575 in 1 POUCH; 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(78847-321)
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