Label: G3TECH HAND SANITIZER- hand sanitizer gel

  • 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 September 17, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.1% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    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.

  • Directions

    • Squeeze a few drops onto palm.
    • Rub onto entire area of hands, including backs, wirsts and between fingers until dry.
    • No rinsing required.
  • Other information

    • Store in a cool dry place
    • Keep away from direct sunlight
  • Inactive ingredients

    Aqua,

    Glycerin,

    Anthemis Nobilis (Chamomile) Flower Water,

    Acrylates/C 10-30 Alkyl Acrylate Crosspolymer,

    Citric Acid,

    Lavandula Angustifolia (Lavender) Oil,

    Aloe Barbadensis Leaf Juice,

    Hydroxypropyl Methylcellulose,

    Curcumin,

    Korean Pine Oil

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Package Label - Principal Display Panel

    60ml NDC: 79176-001-01 60ml label

    500ml NDC: 79176-001-02

    500 ml Label

    1000ml NDC: 79176-001-03

    1000ml label

  • INGREDIENTS AND APPEARANCE
    G3TECH HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79176-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE10 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CURCUMIN (UNII: IT942ZTH98)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    WHITE PINE OIL (UNII: HA5CX6676U)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79176-001-20500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:79176-001-3060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    3NDC:79176-001-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Freshstart Holdings Inc. (117553499)
    Registrant - Freshstart Holdings Inc. (117553499)
    Establishment
    NameAddressID/FEIBusiness Operations
    Freshstart Holdings Inc.117553499manufacture(79176-001)
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