Label: HEALTHY HANDS FOAMING HAND SANITIZER- n/a liquid

  • NDC Code(s): 77617-001-01, 77617-001-02, 77617-001-05, 77617-001-06
  • Packager: Maintex
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 21, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredient

    Benzalkonium Chloride...........................0.1 %

  • Uses

    Uses

    • For hand sanitizing to decrease bacteria on the skin
  • Purpose

    Purpose

    Antimicrobial

  • Warnings

    Warnings

    • For external use only
    • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not ingest.
    • Stop use and ask a doctor if irritation and redness develop and conditions persist.
  • Keep out of reach of children.

    Keep out of reach of children. If swallowed, get medical attention or contact a Poison Conrol Center immediately.

  • Directions

    Directions

    • Apply to hands. Work into a lather and let dry. 
    • Children under 6 years of age should be supervised when using this product.
  • Inert Ingredients:

    Inactive Ingredients

    • water
    • cetrimonium chloride
    • laurtrimonium chloride
    • dihydroxyethyl cocamine oxide
    • glycereth-17 cocoate
    • citric acid 
  • Healthy Hands Foaming Hand Sanitizer

    image description
  • INGREDIENTS AND APPEARANCE
    HEALTHY HANDS FOAMING HAND SANITIZER 
    n/a liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77617-001
    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)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77617-001-024 in 1 PACKAGE09/23/2018
    1NDC:77617-001-013756 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:77617-001-054 in 1 PACKAGE09/23/2018
    2NDC:77617-001-061000 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/23/2018
    Labeler - Maintex (008317307)
    Registrant - Maintex (008317307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(77617-001) , api manufacture(77617-001) , pack(77617-001)