Label: HARMON FACE VALUES HAND SANITIZER SPRAY- alcohol spray

  • 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 February 22, 2010

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  • Active Ingredients

    Ethanol

    Antiseptic

  • Uses

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

    • For external use only
    • Do not use in eye are

    Flammable: Keep away from heat or flame
  • When using this product

    • Keep out of eyes. In case of eye contact, flush eyes thoroughly with water.
    • Avoid contact with broken skin.
  • Stop use and ask a doctor if

    Irritation or redness develops or if condition persists for more than 72 hours.
  • Keep out of reach of Children

    If swallowed, get medical help, or contact a Poison Control Center immediately.

  • Directions

    • Pump one to three sprays onto palms of hands
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry
    • Children under 6 should be supervised when using this product
    • Not recommended for infants
  • Other Information

    • Store at 200 to 250 C (680 to 770 F)
    • Prior to initial use, prime pump by depressing multiple times
    • May discolor certain fabrics
    • Harmful to wood finishes and plastics
  • Inactive Ingredients

    Aloe Vera, D and C Green 5, DI Water, FD and C Yellow 5, Fragrance, Propylene Glycol, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    MM4harmon label jpeg

  • PRINCIPAL DISPLAY PANEL

    MM5harmon single count blister jpeg

  • PRINCIPAL DISPLAY PANEL

    MM6Harmon 3 count blister card

  • PRINCIPAL DISPLAY PANEL

    MM7Harmon one count shipper case

  • PRINCIPAL DISPLAY PANEL

    MM8Harmon three count shipper case

  • INGREDIENTS AND APPEARANCE
    HARMON FACE VALUES  HAND SANITIZER SPRAY
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ethanol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) Ethanol4.65 mL  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (D&C Green #5) , yellow (FD&C Yellow 5) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48871-001-016 in 1 CASE
    112 in 1 CARTON
    11 in 1 BLISTER PACK
    17.5 mL in 1 BOTTLE, SPRAY
    2NDC:48871-001-026 in 1 CASE
    212 in 1 CARTON
    23 in 1 BLISTER PACK
    27.5 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/31/2010
    Labeler - Health-Tech, Inc. (084007889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health-Tech, Inc.084007889manufacture
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