Label: GENTLECARE HAND AND SKIN SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 78181-020-02, 78181-020-07, 78181-020-18, 78181-020-28
  • Packager: PARAGON SOLUTIONS US, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride, 0.13%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses
    ■ For sanitizing to reduce bacteria on the skin.

  • WARNINGS

    Warnings
    For external use only
    When using this product■ Avoid contact with
    eyes. ■ In case of eye contact, flush with water.
    ■ Call doctor if irritation persists.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ Apply 1 - 2 pump to dry hands, rub into skin.
    ■ Supervise children in the use of this product.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Purified Water, Aloe Vera, Propylene Glycol,
    Triethylene Glycol, Polysorbate-20.

  • Principal Display Panel

    GentleCare

    Solutions

    Foaming

    Hand & Skin
    Sanitizer

    • Kills 99.99% of Germs
    • Moisturizes & Conditions
    • Alcohol Free, Sting Free
    • Fragrance Free

    with Aloe Vera
    1.7 fl. oz. (50 mL)

    Sold by:

    GentleCare
    Solutions

    A division of:
    Paragon Solutions US, Inc.
    New Hill, NC 27562

    www.gentlecare.us

    Questions?

    Call Us Toll Free

    1.800.262.8670
    Monday to Friday
    9:00 am to 4:00 pm EST

    1.7 FL OZ

    020-02

    7.5 FL OZ

    020-07

    16.5 FL OZ

    020-18

    1 GAL

    020-28

    res

  • INGREDIENTS AND APPEARANCE
    GENTLECARE HAND AND SKIN SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78181-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78181-020-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    2NDC:78181-020-07221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    3NDC:78181-020-18550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    4NDC:78181-020-283785 mL in 1 JUG; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2020
    Labeler - PARAGON SOLUTIONS US, INC. (069788314)
    Registrant - PARAGON SOLUTIONS US, INC. (069788314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifequest Creations LLC053654857manufacture(78181-020)
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