Label: PREVAIL HAND SANITIZER LEMONGRASS- alcohol gel

  • 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 January 26, 2011

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  • Active Ingredient

    Ethyl Alcohol 62%.................................Antiseptic

  • Purpose

    • To decrease bacteria on the skin that could cause disease.
    • Recommended for repeated use.
  • Warnings

    For external use only. Flammable. Keep away from heat and flame.

  • When using this product

    • Keep out of eyes. In case of contact with eyes, flush throughly with water
    • Avoid contact with broken skin.
  • STOP USE

    If skin irritation develops.

  • Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately.

  • Directions

    • Apply small amount to your palm, rub hands together throughly to coat, continue until hands are dry.
  • Other information

    • Do not store above 105oF
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • INACTIVE INGREDIENT

    Water, Propylene Glycol, Glycerin, Carbomer, Isopropyl Myristate, Tocopheryl (Vitamin E) Acetate, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Yellow 5, Fragrance

  • Questions

    Call (866) 375-6925

  • PRINCIPAL DISPLAY PANEL

    place holder text

    image of lemongrass label

  • INGREDIENTS AND APPEARANCE
    PREVAIL  HAND SANITIZER LEMONGRASS
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL36.58 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-021-0259 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/26/2011
    Labeler - Creation's Garden Natural Products, Inc (839471216)
    Registrant - Creation's Garden Natural Products, Inc (839471216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creation's Garden Natural Products, Inc839471216manufacture
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