Label: LEMON SCENTED ANTISEPTIC HAND SANITIZER 80 ETHYL ALCOHOL- alcohol liquid

  • NDC Code(s): 82127-002-01, 82127-002-02
  • Packager: H&Y Products LLC dba Kolonya Carre
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 80%

    Purpose

    Antiseptic

  • Use

    for hand washing to decrease bacteria on the skin.

  • Warnings

    For external use onlyFlammable, keep away from fire or flame.

    Do not use

    • in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop.
    • condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
  • Inactive ingredients

    Water, Fragrance, Butylphenyl methylpropional, Citral, Citronellol, Geraniol, Limonene, Linalool

  • Package Labeling:82127-002-01

    Outer Package5Inner Package5

  • Package Labeling:82127-002-02

    Outer Package6Inner Package6

  • INGREDIENTS AND APPEARANCE
    LEMON SCENTED ANTISEPTIC HAND SANITIZER 80 ETHYL ALCOHOL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82127-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82127-002-011 in 1 BOX08/01/202107/31/2025
    135 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:82127-002-021 in 1 BOX08/01/202107/31/2025
    290 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/01/202107/31/2025
    Labeler - H&Y Products LLC dba Kolonya Carre (070644433)
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