Label: SHSNH6-3601- isopropyl alcohol gel

  • NDC Code(s): 73870-516-16, 73870-516-33
  • Packager: Shotwell Hydrogenics, LLC
  • 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 April 9, 2021

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  • Drug Facts

  • Active ingredients(s)

    Isopropyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use(s)

    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. Flammable. Keep away from heat or flame.

    Do not use
    • in children less than 2 years of age
    • on open skin wounds
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask for a doctor if irritation 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 this product to avoid swallowing

  • Other information

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

  • Inactive ingredients

    deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate crosspolymer, glycerin, fragrance

  • SPL UNCLASSIFIED SECTION

    Topical Solution

    HAND SANITIZER

  • Packaging

    SHSNH6-3601

  • INGREDIENTS AND APPEARANCE
    SHSNH6-3601 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73870-516
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73870-516-331249 L in 1 CONTAINER; Type 0: Not a Combination Product03/30/2021
    2NDC:73870-516-160.5 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2021
    Labeler - Shotwell Hydrogenics, LLC (108985732)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shotwell Hydrogenics, LLC108985732manufacture(73870-516)
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