Label: LEMON X 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 December 31, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Ethyl Alcohol 73% v/v. Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

    Recommended for repeated use.

  • Warnings

    For external use only. Flammable. Keep away from fire or flame.

  • Do not use

    • When using this product do not use in or near the eyes.
    • In case of contact, rinse eyes thouroughly with water.
  • WHEN USING

    Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • STOP USE

    Discontinue use if irritation or redness develops. If condition persistes for more than 72 hours, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children should only use this product under adult supervision.

  • Directions

    • Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.
    • Recommended for repeated use.
  • Other information

    • Do not store above 105F.
    • May discolor some fabrics.
    • Harmful to wood finishes and plastics.
  • Inactive Ingredients

    Deionized water, Glycerin, Carbomer, Triethanolamine, Fragrance, Vitamin E (Tocopheryl Acetate), FD&C Yellow No. 6

  • Package Label - Principal Display Panel

    1 Gallon 128 oz. (3.78L) NDC: 77584-103-01

    Lemon X Front Panel

  • INGREDIENTS AND APPEARANCE
    LEMON X HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77584-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 22 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.5 mL  in 100 mL
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.0001 mL  in 100 mL
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 1.5 mL  in 100 mL
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.75 mL  in 100 mL
    TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH) 0.25 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77584-103-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    Labeler - DCI Binzel Chemical Laboratories (117517678)
    Registrant - DCI Binzel Chemical Laboratories (117517678)
    Establishment
    NameAddressID/FEIBusiness Operations
    DCI Binzel Chemical Laboratories117517678manufacture(77584-103)
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