Label: YANKEE CANDLE HAND SANITIZER WITH MOISTURIZER BEACH WALK- 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 August 31, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 62.5%

  • Purpose

    Antiseptic Cleanser

  • Use

    To help reduce bacteria on hands.

  • Warnings

    For external use only.

    Flammable, keep away from fire, flame or sparks.

    Do not use on damaged or broken skin | in or near eyes, ears or mouth | or on children less than 2 months of age.

    When using this product if in the eyes rinse thoroughly with water | discontinue use if irritation and/or redness develops.

    Stop use and ask doctor if irritation or rash appears on the skin and persists for 72 hours.

    Keep out of reach of children and pets. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply product onto hands, spread thoroughly and rub dry.
    • Children under 6 years of age should be supervised by an adult to avoid swallowing.
  • Other information

    • Store between 59-86F (15-30C)
    • Avoid freezing and excessive heat above 104F (40C)
    • May discolor certain fabrics or surfaces
    • Harmful to wood finishes and plastics
  • Inactive ingredients

    Aqua (Water), Propylene Glycol, Dimethicone PEG-7 Isostearate, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Denatonium Benzoate, Tert Butyl Alcohol, 2-Amino-2-Methyl-1-Propanol, 2-Methylamino-2-Methyl-1-Propoanol, Tocopherol Acetate (Vitamin E), fragrance.

  • Questions?

    Call 877-803-6890

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY YANKEE CANDLE, INC.
    16 YANKEE CANDLE WAY, SOUTH DEERFIELD, MA 01373 USA

  • PRINCIPAL DISPLAY PANEL - 236.6 ML Bottle Label

    YANKee
    CANDLe®

    GEL HAND
    SANITIZER
    with moisturizer

    BEACH
    WALK®
    with essential oils

    KILLS 99.99% OF
    MOST GERMS*

    CONTAINS ALOE
    & VITAMIN E

    62.5% ALCOHOL

    NET WT 8 FL OZ (236.6 ML)

    PRINCIPAL DISPLAY PANEL - 236.6 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    YANKEE CANDLE HAND SANITIZER WITH MOISTURIZER   BEACH WALK
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80123-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE PEG-7 ISOSTEARATE (UNII: JVS3399FNW)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80123-003-01118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
    2NDC:80123-003-023 in 1 PACKAGE10/26/2020
    2118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:80123-003-03236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
    4NDC:80123-003-042 in 1 PACKAGE10/26/2020
    4236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A10/26/2020
    Labeler - THE YANKEE CANDLE COMPANY INC (066983586)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tri-Pac, Inc.020844956MANUFACTURE(80123-003)
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