Label: HAND SANITIZER 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 January 6, 2022

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  • PURPOSE

    Antiseptic

  • Warnings

    For external use only. Flammable, Keep away from fire and flame.

    Do not use in the eyes

  • Do not use

    • Do not use in the eyes
  • Stop Use and Ask a Doctor If:

    Stop use and ask a doctor if:

    - irritation and redness develop.

    - Condition persists for more than 72 hours.

  • DIRECTIONS

    • Spray hands or body with product as many times as needed and allow to dry without wiping
  • Other information

    • Store below 110 F ( 43C) . May Discolor certain fabrics
  • Active Ingredient

    Ethyl Alcohol 60%

  • Stop USe and Ask Doctor if

    Stop use and ask a doctor if:

    - rritation and redness develop.

    - Condition persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

  • USE

    For hand cleansing to decrease bacteria on the skin

  • Inactive Ingredients

    Water, glycerin, citrus grands seed extract, lemon peel oil, rosemary leaf oil, organic eucalyptus leaf oil, organic clove bud flower oil, organic cinnamon leaf oil

  • Package Label

    2 FL OZ (60 ml) NDC: 80751-400-02

    HELLO

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80751-400
    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
    LEMON OIL (UNII: I9GRO824LL)  
    ROSEMARY (UNII: IJ67X351P9)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    CITRUS FRUIT (UNII: XDK00Z8012)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80751-400-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/06/2022
    Labeler - Aromas Para El Alma S.A. (853174212)
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