Label: FRESHNAILS THE UNDERNAIL SANITIZER- isopropyl alcohol 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 November 18, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients

    Isopropyl Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use

    •  For antiseptic hand cleaning to kill and decrease germs and bacteria on the skin, particularly on the fingertip and under the fingernail area.
    •  For personal hand hygiene and recommended for repeated use.
    • Dries in seconds.
  • WARNINGS

    Warnings

    •  Flammable. Keep away from open flame and sources of heat.
    •  For external use only.
    •  Keep out of reach of children.
    •  If digger (pick) is used, gently and carefully apply under fingernails.
    • Do not use if seal is broken.
    • Avoid contact with eyes, if contact occurs, flush with water.
    • Stop use and consult a healthcare professional if irritation develops.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions

    •  Rub product onto fingertip skin and under fingernails and allow to dry.
    • Use as part of your daily cleansing routine.
  • INFORMATION FOR PATIENTS

    Other Information

    Store at room temperature: 15° - 30° (59° - 86° F)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Ginseng (Panax Ginseng) Extract, Glycerin, Polysorbate 20, Purified Water, Tea Tree Essential Oil

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FRESHNAILS  THE UNDERNAIL SANITIZER
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58665-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CUCUMBER (UNII: YY7C30VXJT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58665-001-021 in 1 CARTON
    15.75 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/19/2013
    Labeler - TWB Strategic Investments Inc. (203161039)
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