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

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SANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]
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NDC 61010-1122-3, 61010-1122-4, 61010-1122-6, 61010-1122-7
Set ID 6ac9df02-225d-4115-a9c6-a492faafe68a
Category HUMAN OTC DRUG LABEL
Packager Safetec of America, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Chloroxylenol (PCMX) 0.6%

  • Purpose

    Antiseptic

  • Uses

    For handwashing 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 the eyes. If contact occurs, rinse thoroughly with water

    Stop use and ask a doctor if irritation or redness develop and persist 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 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

  • Inactive ingredients

    aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

  • PRINCIPAL DISPLAY PANEL - 1 GALLON BOTTLE

    NDC 61010-1122-6

    Safetec

    SaniWash

    Antimicrobial Hand Soap

    Effective against germs

    Cleans dirty hands yet gentle on skin

    Mild pleasant fragrance with Aloe

    Reorder No. 34455

    NET CONTENTS

    1 gal (3.785 L)

    PRINCIPAL DISPLAY PANEL - 1 GALLON BOTTLE
  • PRINCIPAL DISPLAY PANEL - 800 mL Bag-In-Box

    Manufactured by
    Safetec

    Safetec of America, Inc.

    Buffalo, NY 14215

    1-800-456-7077 www.safetec.com

    Reorder No. 34465

    NDC 61010-1122-4

    27.05 fl. oz. (800 ml.)

    SaniWash

    Antimicrobial Hand Soap

    PRINCIPAL DISPLAY PANEL - 800 mL Bag-In-Box
  • PRINCIPAL DISPLAY PANEL - 16 oz. BOTTLE

    NDC 61010-1122-3

    SaniWash

    Antimicrobial Hand Soap

    Effective against germs

    Cleans dirty hands yet gentle on skin

    Mild pleasant fragrance with Aloe

    NET CONTENTS

    16 fl. oz. (473 ml)

    Safetec

    Reorder No. 34452

    PRINCIPAL DISPLAY PANEL - 16 oz. BOTTLE
  • Principal Display Panel - Bottle Label

    NDC 61010-1122-7

    Safetec

    SaniWash®

    Antimicrobial Hand Soap

    Effective against germs

    Cleans dirty hands yet gentle on skin

    Mild pleasant fragrance with Aloe

    NET CONTENTS

    55 gal (208.2 L)

    Reorder No. 34457

    Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    SANIWASH ANTIMICROBIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-1122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol0.0060 mg  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)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-1122-63785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/22/2014
    2NDC:61010-1122-4800 mL in 1 BAG; Type 0: Not a Combination Product04/22/201404/12/2017
    3NDC:61010-1122-3473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/22/2014
    4NDC:61010-1122-7208198 mL in 1 DRUM; Type 0: Not a Combination Product04/22/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2014
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(61010-1122)
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