Label: WECLEAN FOAM HAND SANITIZER EUCALYPTUS- benzalkonium chloride liquid

  • NDC Code(s): 77006-002-01, 77006-002-02
  • 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

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Benzalkonium chloride: 0.20% Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • 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.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

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

    PEG-40 hydrogenated castor oil

    Polyaminopropyl biguanide

  • Package Label - Principal Display Panel

    NDC: 77006-002

    RNL

  • INGREDIENTS AND APPEARANCE
    WECLEAN FOAM HAND SANITIZER EUCALYPTUS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-002
    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
    PEG-50 HYDROGENATED CASTOR OIL (UNII: R07D3A9614)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77006-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:77006-002-02250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    Labeler - WeCool Toys, Inc. (080480202)
    Registrant - WeCool Toys, Inc. (080480202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(77006-002) , label(77006-002) , pack(77006-002)