Label: CRAZY CLEANZ FOAMING HAND SANITIZER - EUCALYPTUS- benzalkonium chloride liquid

  • NDC Code(s): 77006-010-01, 77006-010-02
  • Packager: WeCool Toys, Inc.
  • 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 January 12, 2022

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT(S) Purpose

    Benzalkonium Chloride 0.10%..................Antiseptic

  • PURPOSE

    Use(s): Helps eliminate bacteria on hands.

  • WARNINGS

    WARNINGS: For external use only

  • INDICATIONS & USAGE

    DO NOT USE

    * in children less than 2 months of age

    * On open skin wounds

    WHEN USING THIS PRODUCT keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thouroughly with water.

    STOP USE AND ASK A DOCTOR if irritation or rash occures. 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.

  • DOSAGE & ADMINISTRATION

    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.

  • STORAGE AND HANDLING

    Other Information

    *Store between 15-30C (56-86F)

    *Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Deionized water
    Glycerin
    Didecyldimonium chloride
    FD&C Blue 1
    FD&C Yellow 5
    Fragrance - Eucalyptus
    Limonene
    Linalool

    PEG-40 hydrogenated castor oil

    Polyaminopropyl biguanide

  • PRINCIPAL DISPLAY PANEL

    NDC 77006-010

    RNLabel

  • INGREDIENTS AND APPEARANCE
    CRAZY CLEANZ FOAMING HAND SANITIZER - EUCALYPTUS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE200 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    POLYOXYL 50 HYDROGENATED CASTOR OIL (UNII: R07D3A9614)  
    DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)  
    WATER (UNII: 059QF0KO0R)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77006-010-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/18/2020
    2NDC:77006-010-02250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/2020
    Labeler - WeCool Toys, Inc. (080480202)
    Registrant - WeCool Toys, Inc. (080480202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775label(77006-010) , manufacture(77006-010) , pack(77006-010)
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