Label: GRABPAK ANTIBACTERIAL HAND- chloroxylenol soap

  • 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 September 21, 2020

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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.3%

    Purpose

    Antibacterial 

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if 

    irritation or redness develops.

    Keep out of reach of children.

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

  • Directions

    • Apply onto wet hands, lather for at least 30 seconds and rinse thoroughly.
    • To refill a small size bottle, pour as needed.
  • Inactive ingredients

    WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, GLYCERIN, COCAMIDE METHYL MEA, SODIUM CHLORIDE, FRAGRANCE, DMDM HYDANTION, CITRIC ACID, DISODIUM EDTA, DYE.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    GRABPAK ANTIBACTERIAL HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80621-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80621-000-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/05/2020
    Labeler - Lyte Ltd (220069352)
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