Label: WECLEAN HAND SANITIZER PUMPKIN SWIRL- alcohol liquid

  • 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

    Alcohol 62% v/v. Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    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. Flammable. Keep away from heat or flame.

  • 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.

  • DOSAGE & ADMINISTRATION

    · 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

    · Store between 15-30C (59-86F)

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

  • INACTIVE INGREDIENT

    Acrylates/C10-30 alkyl acrylate crosspolymer

    Ascorbyl palmitate

    Butylphenyl methylpropional
    Celluose

    Citronellol

    Coumarin

    Deionized waterGeraniol

    Fragrance - Pumpkin swirl scent

    GlycerinHexyl cinnamal

    Hydroxycitronellal

    Hydroxypropyl methylcellulose
    Jojoba esters
    Lactose
    Limonene
    LinaloolRed 4 (CI 14700)

    Tocopheryl acetate
    Triethanolamine

    Yellow 5 (CI 19140)


  • PRINCIPAL DISPLAY PANEL

    NDC 77006-030

    Label

  • INGREDIENTS AND APPEARANCE
    WECLEAN HAND SANITIZER PUMPKIN SWIRL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL58.36 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (S)- (UNII: 8RSY5Y5658)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    COUMARIN (UNII: A4VZ22K1WT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77006-030-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/26/2020
    Labeler - WeCool Toys (080480202)
    Registrant - WeCool Toys (080480202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy545291775manufacture(77006-030) , pack(77006-030) , label(77006-030)
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