Label: GIZMOCLEAN- hands free 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 October 3, 2022

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    keep out of eyes, ears, and mouth

    In case of contact with eyes, rinse thorougly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when susing this product to avoid swallowing.
  • Other information

    Store between 59-86F (15-30C). • Avoid freezing and excessive heat above 104F (40C).

  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP, fragrance

  • Package Label - Principal Display Panel

    Cucumber Label80 mL NDC 83026-111-12

  • INGREDIENTS AND APPEARANCE
    GIZMOCLEAN 
    hands free sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83026-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83026-111-1280 mL in 1 BOTTLE; Type 0: Not a Combination Product10/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/03/2022
    Labeler - Natscent Inc (114571723)