Label: WECLEAN HAND SANITIZER PUMPKIN SWIRL SCENT- ethyl alcohol 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)

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    helps eliminate bacteria on hands

  • Warnings

    For external use only.
    Flammable, Keep away from heat or flame,
    Do not use
    On 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

    Acrlates/(10-30 alkyl acrylate crosspolymer, Ascorbyl palmitate, Cullose, Fragrance (parfum),
    Geraniol, Glycerin, HexyI cinnamal, Hydroxypropyl methylcellulose, Jojoba Esters, Lactose,
    Limonene, Linalool, Red 4(C( 14700), Tocophery| acetate, Triethanolamine, Water(Aqua), Yellow 5(C| 19140).

  • Package Label - Principal Display Panel

    11

  • INGREDIENTS AND APPEARANCE
    WECLEAN HAND SANITIZER PUMPKIN SWIRL SCENT 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-923
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-923-01250 mL 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(51706-923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-923)
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