Label: SANITIZER- 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 December 31, 2018

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  • Active Ingredient

    Active Ingredient

    Ethyl alcohol 60%

  • Uses:

    Uses:

    • Helps decrease bacteria on skin
    • Recommended for repeated use
  • Purpose

    Purpose

    Antiseptic

  • Warnings

    Warnings

    For external use only. Avoid contact with eyes. If contact occurs, rinse with water.

    Flammable, keep away from fire or flame.

    Keep out of reach of children. If swallowed, get medical help or contat a Poison Control Center right away.

    For children under 6, use only under adult supervision. Not recommended for infants.

  • Directions

    Directions:

    Shake well.

  • DOSAGE & ADMINISTRATION

    Spray onto hands and rub thorughly.

  • Inactive Ingredients

    Inactive ingredients

    aqua (water), Mentha piperita (peppermint) leaf essential oil, Mentha arvensis (corn mint) leaf essential oil, Aloe barbadensis leaf juice

  • Principal display panel

    Cool Burst drug facts

    All-Natural Sanitizer Cool Burst 50ml PDP

  • INGREDIENTS AND APPEARANCE
    SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70143-1002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70143-1002-150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/08/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/08/2015
    Labeler - Gandang Kalikasan USA Inc. (024656271)
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