Label: SMD SANITIZER SOLUTIONS HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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, 2021

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  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only

  • Do Not Use

    • In children less than 2 months of age
    • On open skin wounds
  • When using this product

    When using this product keep out of eyes, ears, and mouth.
    In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use or ask a doctor if

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

  • 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 using product to avoid swallowing.
  • Other Information

    • Store between 15-30 0C (59-86 0F)
    • Avoid freezing and excessive heat above 40 0C (104 0F)
  • Inactive ingredients

    Carbapol 20, glycerin, proylene glycol, water

  • SMD SANITIZER SOLUTIONS HAND SANITIZER

    smd 55

  • INGREDIENTS AND APPEARANCE
    SMD SANITIZER SOLUTIONS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73787-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73787-114-01208000 mL in 1 DRUM; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/27/2020
    Labeler - FGD, LLC (111927555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodwin Co.806987483manufacture(73787-114)
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