Label: SERVO-STAT P- chloroxylenol liquid

  • NDC Code(s): 76378-017-01, 76378-017-02, 76378-017-03, 76378-017-04
  • Packager: Enzyme Solutions, Inc.
  • 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 7, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    PCMX (para-chloro-meta-xylenol) 0.6%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use

    for hand-washing to decrease bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    When using this product

    Do not get in eyes

    If contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    Irritation and redness develop

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Ready to use

    Do not dilute

    Wet hands and forearms

    Apply 5 milliliters (palmful) to hands and forearms

    Rinse thoroughly

  • INACTIVE INGREDIENT

    Ingredients

    Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Tetrasodium EDTA, Propylene Glycol, Fragrance, Sodium Chloride, Boric Acid, Glycol Stearate, PEG-75 Lanolin, DMDM Hydantoin, Aloe Vera, FDC Red #40, FDC Yellow #6

  • PRINCIPAL DISPLAY PANEL

    Servo-Stat P

    Antiseptic Hand Wash

    11106R-A1000

    1000 ml (33.8 fl oz.)

    container label

  • INGREDIENTS AND APPEARANCE
    SERVO-STAT P 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76378-017-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
    2NDC:76378-017-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
    3NDC:76378-017-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
    4NDC:76378-017-041000 mL in 1 BAG; Type 0: Not a Combination Product12/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2011
    Labeler - Enzyme Solutions, Inc. (004994559)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enzyme Solutions, Inc.004994559manufacture(76378-017)
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