Label: MEDSHIELD PRODUCTS- hand sanitizer liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    75446-111-02, 75446-111-04, 75446-111-06, 75446-111-08, view more
    75446-111-10, 75446-111-12, 75446-111-14, 75446-111-16, 75446-111-18, 75446-111-20, 75446-111-22, 75446-111-24, 75446-111-26, 75446-111-28, 75446-111-30, 75446-111-32, 75446-111-34, 75446-111-36
  • Packager: HWL Holdings, 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 December 9, 2021

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

  • Active Ingredient(s)

    Benzalkonium Chloride 0.1% Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    to decrease bacteria on the skin that could cause disease

  • Warnings

    For external use only-hands

  • WHEN USING

    keep out of eyes In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    if skin irritation develops.

  • 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.

  • Directions

    • Rub thoroughly over all the surfaces of both hands.
    • Rub hands together briskly until dry.

  • Inactive ingredients

    glycerol, purified water USP

  • Package Label - Principal Display Panel

    100 mL NDC: 75446-111-14100 mL NDC: 75446-111-14

  • INGREDIENTS AND APPEARANCE
    MEDSHIELD PRODUCTS 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75446-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75446-111-0430 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    2NDC:75446-111-0650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    3NDC:75446-111-0860 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    4NDC:75446-111-1075 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    5NDC:75446-111-1280 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    6NDC:75446-111-14100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    7NDC:75446-111-16118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    8NDC:75446-111-18236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    9NDC:75446-111-20250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    10NDC:75446-111-22473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    11NDC:75446-111-24946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    12NDC:75446-111-261000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    13NDC:75446-111-281183 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    14NDC:75446-111-301892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    15NDC:75446-111-323785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    16NDC:75446-111-3410000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    17NDC:75446-111-3612000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    18NDC:75446-111-0218 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    Labeler - HWL Holdings, LLC (058630887)
    Establishment
    NameAddressID/FEIBusiness Operations
    HWL Holdings, LLC058630887manufacture(75446-111)