Label: JUSTICE COOL CANDY PINK SCENTED ANTI-BACTERIAL HAND SANITIZER- 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 4, 2018

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  • Drug Facts

  • Active ingredient

    Alcohol 62%

    Purpose

    Antiseptic

  • Use

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

    Flammable, keep away from fire or flame.

    For external use only.

    Do not use

    in the eyes or apply over large areas of the body.

    In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances.

    Stop use and ask a doctor if

    Irritation persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • Supervise children in the use of this product.
  • Other information

    • Store below 105°F (40.5°C).
    • May discolor some fabrics.
  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Fragrance, Carbomer, Triethanolamine, Mica, FD&C Red No.40, D&C Red No.33.

  • Package Labeling:

    Outer Package cInner Package

  • INGREDIENTS AND APPEARANCE
    JUSTICE COOL CANDY PINK SCENTED ANTI-BACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60637-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MICA (UNII: V8A1AW0880)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60637-074-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product04/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/27/2016
    Labeler - Tween Brands, Inc (965758188)
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