Label: AVAGARD D- alcohol lotion

  • NDC Code(s): 48878-0231-7
  • Packager: 3M ESPE Dental Products
  • 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 April 27, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol, 61% w/w

  • Purpose

    Antiseptic

  • Uses

    instant healthcare personnel hand antiseptic

    • reduces bacteria that potentially can cause disease
    • recommended for repeated use
  • Warnings

    Flammable, keep away from fire or flame.

    For external use only

    When using this product

    • Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation, or sensitization develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to clean, dry hands. Wet hands thoroughly with product and allow to dry.

  • Other information

    • Store at 20-25°C (68-77°F)
  • Inactive ingredient

    beheneth-10, behenyl alcohol, C20-40 pareth-24, cetyl palmitate, diisopropyl dimer dilinoleate, dimethicone, glycerin, polyethylene glycol, squalane, water

  • Principal Display Panel

    NDC 48878-0231-7

    3M ESPE

    Avagard™ D

    Instant Hand Antiseptic

    With Moisturizers

    Contains: 61% w/w ethyl alcohol

    Destroys Bacteria. Not Your Skin.

    Flammable, keep away from fire or flame, heat,

    sparks and sources of static discharge.

    REF 2317

    500 ml • 16fl oz

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    AVAGARD D 
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-0231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol530.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Beheneth-10 (UNII: 313S43DM16)  
    Docosanol (UNII: 9G1OE216XY)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol, unspecified (UNII: 3WJQ0SDW1A)  
    Squalane (UNII: GW89575KF9)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48878-0231-712 in 1 CASE04/28/2011
    1500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/1999
    Labeler - 3M ESPE Dental Products (801390852)