Label: ANTI-BACTERIAL DAYOFF HAND SANITIZER- 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 April 13, 2022

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  • Active ingredient

    Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    Decrease bacteria on hands.

  • Warnings

    Flammable: Keep away from heat of flame.

    For external use only.

  • Do not use

    • In children less than 2 months of age
    • On damaged skin or broken skin
  • When using this product

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • Stop use and ask a doctor

    If irritation and redness develop or increase.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Cente right away.

  • Directions

    • Rub a dime size drop into hands.
  • Other information

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

  • Inactive ingredients

    Water(Aqua), Glycerin, Fragrance (Parfum), Carbomer, Lactose, Cellulose, Propylene Glycol, Hydroxypropyl Methylcellulose, Aminomethyl Propanol, L-Menthol, Jojoba Esters, Tocopheryl Acetate, Ascorbyl Palmitate, Mentha Piperita (Peppermint), Leaf Extract, Pinus Densiflora Leaf Extract, FD&C Yellow No. 5, FD&C Blue No. 1, Ultramarines.

  • PRINCIPAL DISPLAY PANEL

    DAYOFF

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL DAYOFF HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82697-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL136.4 mL  in 220 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82697-221-01220 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/20/2022
    Labeler - GHOST STORIES (695261181)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Korea Co., Ltd.688729438manufacture(82697-221)
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