Label: THOMAS AND FRIENDS HAND SANITIZER- 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 December 31, 2019

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  • Drug Facts

  • Active Ingredient

    CHLOROXYLENOL 0.05%

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria and germs on the skin.

  • Warning

    Flammable. Keep away from fire or flame. For external use only

    • Stop use and ask a doctor if irritation or redness develops and persists.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. In case of accidental digestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Place enough product in palm to cover hands and rub hands together briskly until dry. • Children under 6, use only under adult supervision. • Not recommended for infants.

  • Inactive Ingredients

    Aqua, Propylene Glycol, Phenoxyethanol, Coceth-7, Ppg-1-peg-9 Lauryl Glycol Ether, Peg-40 Hydrogenated Castor Oil, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Parfum, Sodium Hydroxide.

  • Other Information

    • Do not store above 100° F (38° C). • May discolor some fabrics. • Harmful to wood finishes and plastics.

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    HAND SANITIZER
    DESINFECTANTE DE MANOS
    DESINFECTANT POUR MAINS

    DESIGNED IN U.S.A.
    MANUFACTURED IN CHINA

    www.smartcareus.com
    QUESTIONS OR COMMENTS?
    1-877-274-8358 TOLL FREE IN US
    1-909-434-0911 INTERNATIONAL

  •  Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    THOMAS AND FRIENDS HAND SANITIZER 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCETH-7 (UNII: 58Y261JLH5)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-009-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/06/2017
    Labeler - Ashtel Studios, Inc (148689180)
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