Label: FIKES FOAMING ANTI-MICROBIAL FOOD SERVICE HAND WASH- chloroxylenol liquid

  • 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 September 3, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient:

    Chloroxylenol (1.49% w/w)

  • Purpose:

    Anti-Microbial Hand Cleanser

  • Uses

    • Helps reduce bacteria that potentially can cause disease
    • Helps prevent cross contamination by hand contact
  • Warnings

    • For external use only
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. In case of eye contact flush with water for 15 minutes. If irritation persists, get medical attention. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
    • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
    • Do not contaminate water, food or feed by storage and disposal.
  • Directions

    • Apply cleaner to palm of hand
    • Lather and scrub hands (including fingers, wrist, and cuticles) vigorously for 60 seconds
    • Rinse with water until all cleaner is removed from hands
    • Dry completely (incomplete drying may lead to chapped skin).
  • Inactive Ingredients

    Water, 2-Propanol, Sodium Laureth Sulfate, Cocoamidopropyl Betaine, Cocoamphoproprionate,
    Cocoamide, Hydroxyethyl Cellulose, Triclosan, FD&C Yellow #5, FD&C Red #40.

    The container is coded for Recycling

    510-003-100-501

    Manufactured for:
    Fikes Northwest, Corp.
    13401 E. Trent Ave., Spokane Valley, WA 99216
    (509) 926-0534 • (509) 755-0370 Fax
    fikesnw@att.net • www.fikesnorthwest.com

  • Principal Display Panel - Bottle Label

    Bottle Label:

    FIKES

    Foaming Anti-Microbial

    Food Service Hand Wash

    An Anti-Microbial Lotion Hand Wash

    Formulated To Clean Effectively,

    Yet Gently. Reduces Total Cost Per Hand Wash

    Keep Out Of Reach Of Children

    CAUTION

    See back panel for additional precautionary information.

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIKES FOAMING ANTI-MICROBIAL FOOD SERVICE HAND WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50036-571
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol15.75 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium laureth sulfate (UNII: BPV390UAP0)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    hydroxyethyl cellulose (2000 CPS at 1%) (UNII: S38J6RZN16)  
    isopropyl alcohol (UNII: ND2M416302)  
    coco diethanolamide (UNII: 92005F972D)  
    triclosan (UNII: 4NM5039Y5X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50036-571-053785 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/28/1998
    Labeler - Fikes Northwest, Corp. (167376284)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE
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