Label: CRAZY CLEANZ HAND SANITIZER EUCALYPTUS SCENTED- benzalkonium chloride gel

  • 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 March 21, 2022

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.1%

  • Purpose

    Antiseptic

  • Use

    helps eliminate bacteria on hands

  • Warnings

    For external use only.
    Do not use
    In children less than 2 months of age. on open skin wounds
    When using this product keep out of eyes, ear, and mouth.
    In case of contact with eve, rinse eyes thouroughly with water
    Stop use and ask a doctor if irritation or rash occurs,
    These may be a sign of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. except under adult supervision.

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

  • Directions

    Place enough product on hands to cover all surfaces.
    Rub hands together until dry.
    Supervise children under 6 years of age When using this product
    to avoid swallowing.

  • Inactive ingredients

    Blue 1(I 42090), Didecyldimonium chloride, Fragrance (Parfum), Glycerin,
    Limonene, Linalool, PEG-40 hydrogenated castor oil,
    Polyaminopropyl biguanide, Water(Aqua), Yellow 5(CI 19140),

  • Package Label - Principal Display Panel

    12

  • INGREDIENTS AND APPEARANCE
    CRAZY CLEANZ HAND SANITIZER EUCALYPTUS SCENTED 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-919
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-919-0130 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    2NDC:51706-919-02250 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    3NDC:51706-919-0350 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    Labeler - Landy International (545291775)
    Registrant - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wecool Toys080480202label(51706-919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-919)
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