SANIWASH ANTIMICROBIAL FOAMING HAND (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC. ]

SANIWASH ANTIMICROBIAL FOAMING HAND (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC. ]
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NDC 61010-8600-1
Set ID bab4ca5f-01c6-4146-b18f-c22cbe0fe13b
Category HUMAN OTC DRUG LABEL
Packager Safetec of America, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Chloroxylenol (PCMX)

  • Purpose

    Antiseptic

  • Uses

    • For hand washing to decrease bacteria on the skin.
    • Recommended for repeated use
  • Warnings

    For external use only.

    When using this product

    • supervise children under 6
    • do not use in eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask doctor if irritation or redness develop and 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 and forearms. Apply 5 millimeters (teaspoonful) or palmful to hand and forearm. Scrub thoroughly for 30 seconds. Rince and repeat.

  • Inactive ingredients

    aloe vera, calblend clear surfactant blend, DMDM hydantoin, fragrance, propylene glycol, purified/deionized water, tetrasodium EDTA, vitamin E acetate

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL -18.6 fl. oz

    NDC 61010-8600-1

    Safetec

    Saniwash

    Antimicrobial Foaming Hand Soap

    Effective against germs

    Cleans dirty hands yet gentle on skin

    Mild pleasant fragrance with Aloe

    Manufactured by

    Safetec

    Safetec of America, Inc

    Buffalo, NY 14215

    1-800-456-7077 www.safetec.com Reorder No. 34456 Net Contents

    18.6 fl. Oz (550 ml)

    PRINCIPAL DISPLAY PANEL -18.6 fl. oz
  • INGREDIENTS AND APPEARANCE
    SANIWASH ANTIMICROBIAL FOAMING HAND 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol0.0060 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-8600-1550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/13/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/13/2014
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(61010-8600)

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