Label: NOVAGEL ALCOHOL-FREE FOAMING HAND SANITIZER- benzalkonium chloride hand sanitizer liquid

  • 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 28, 2020

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  • Principle Display Panel

    Label

    Active Ingredient

    Active Ingredient Purpose

    Benzalkonium chloride 0.1% Antimicrobial

    Use

    To decrease bacteria on skin

    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.

    Warning

    Warnings. For external use only.

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stope use and ask a doctor if irritation or rash appears and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

    Directions

    Directions - Pump a small amount of foam onto palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

    Inactive ingredients

    Inactive ingredients- water, glycerin, sodium lauryl sulfate, fragrance

    Dosage and Adminstration Section

    Benzalkonium Chloride 0.1%

    Directions - Pump a small amount of foam onto palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

    Purpose Section

    Purpose

    Antimicrobial

  • INGREDIENTS AND APPEARANCE
    NOVAGEL ALCOHOL-FREE FOAMING HAND SANITIZER 
    benzalkonium chloride hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78360-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 97.1 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78360-001-0159.15 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/26/2020
    Labeler - Zhejiang Hongshiliang Health Technology Co Ltd (553365550)