Label: NO-WASH ANTIBACTERIAL- ethanol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    77331-001-01, 77331-001-02, 77331-001-03, 77331-001-04, view more
    77331-001-05, 77331-001-06, 77331-001-07, 77331-001-08, 77331-001-09, 77331-001-10, 77331-001-11, 77331-001-12, 77331-001-13, 77331-001-14
  • Packager: MAJESTIC GROUP 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 May 11, 2020

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

  • Active Ingredient

    Ethyl Alcohol

  • Purpose

    Antimicrobial

  • Uses

    Hand-Sanitizer helps to reduce the amount of disease causing bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    • Do not use this hand sanitizer  on or near the eyes.In case of accidental contact, flush eyes thoroughtly with water.
    • Do not use on broken skin: Do not inhale or ingest.
    • In case of skin irritation please stop use and talk to doctor.

  • Directions

    • Place enough product in your palm to thoroughly cover your hands. 
    • Rub hands togerher thoroughly until dry.
    • For children under 6 years old use only under adult supevision :Not recommended for use on infants.
  • Keep out of reach of children

    If accidentally  swallowed,  contact the  Poison Control Center or get medical help immediately.

  • Other Information

    • Do not store above 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive Ingredient

    Water(Aqua),Carbomer,Glycerin,Triethanolamine

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    NO-WASH ANTIBACTERIAL 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77331-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77331-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    2NDC:77331-001-0220 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    3NDC:77331-001-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    4NDC:77331-001-0440 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    5NDC:77331-001-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    6NDC:77331-001-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    7NDC:77331-001-0780 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    8NDC:77331-001-08100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    9NDC:77331-001-09120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    10NDC:77331-001-10250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    11NDC:77331-001-11300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    12NDC:77331-001-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    13NDC:77331-001-132000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    14NDC:77331-001-145000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2020
    Labeler - MAJESTIC GROUP LLC (080252816)