Label: ANTISEPTIC HAND SANITIZING GEL- alcohol 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 August 28, 2020

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

  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

    Purpose

    Antiseptic

  • Uses

    for hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Do not use

    • in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop.
    • condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Inactive ingredients

    C10-30 Alkyl Acrylate Crosspolymer, Glycerol, Triethanolamine, Water

  • Questions or Comments:

    1-(929)-407-2604

  • Package Labeling:250ml

    Label

  • Package Labeling:500ml

    Label2

  • Package Labeling:5L

    Label3

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZING GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79700-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79700-000-00250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
    2NDC:79700-000-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
    3NDC:79700-000-025000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/25/2020
    Labeler - Jennychem Limited (222164241)