Label: ANTIBACTERIAL- alcohol gel

  • NDC Code(s): 77955-004-02
  • Packager: Custom Chemical Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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  • Active ingredients

    Chloroxylenol 1%

  • Purpose

    Antimicrobial

  • Uses

    • For handwashing to decrease bacteria on the skin that could cause disease
    • Recommended for repeated use
  • Warnings

    For external use only: hands

    When using this productavoid contact with eyes.

    In case of contact, flush eyes with water.

    Stop use and ask a doctorif irritation or redness develops, or if 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

    Apply product and work into a lather.

    Rinse well with potable water and dry hands thoroughly.

  • Inactive ingredients:

    Water, Propylene glycol, Ammonium Lauryl sulfate, Ammonium laureth sulfate, Tetrasodium EDTA, Sodium chloride, Glycerin, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    container labelbcontainer labelf

    ANTIBACTERIAL GEL SOAP

    (NSF E2 Registered)

    UniFirst Corporation #88UI 1L(1000ml., 33.8 US fl. oz)

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77955-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.01 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77955-004-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/19/2021
    Labeler - Custom Chemical Solutions (081096319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(77955-004)
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