Label: SERVO-STAT P FOAM ANTISEPTIC HAND WASH- chloroxylenol liquid

  • NDC Code(s): 76378-022-01, 76378-022-02
  • 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 14, 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 into 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 (teaspoonful) or palmful to hands and forearms

    scrub thoroughly for 1 minute and rinse

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FDC Blue # 1, FDC Yellow #5

  • PRINCIPAL DISPLAY PANEL

    Servo-Stat P

    Foam Antiseptic Hand Wash

    NDC # 76378-022-02

    11108R-FM1000

    1000 ml (33.8fl oz.)

    container label

  • INGREDIENTS AND APPEARANCE
    SERVO-STAT P FOAM ANTISEPTIC HAND WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-022
    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 LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    BORIC ACID (UNII: R57ZHV85D4)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76378-022-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2018
    2NDC:76378-022-021000 mL in 1 BAG; Type 0: Not a Combination Product12/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/14/2018
    Labeler - Enzyme Solutions, Inc. (004994559)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enzyme Solutions, Inc.004994559manufacture(76378-022)
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