Label: CELOX ULTRA- alcohol liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    75990-007-01, 75990-007-03, 75990-007-05, 75990-007-06, view more
    75990-007-07, 75990-007-08, 75990-007-09, 75990-007-10, 75990-007-11, 75990-007-12, 75990-007-13, 75990-007-14, 75990-007-15, 75990-007-16, 75990-007-17, 75990-007-18, 75990-007-24, 75990-007-27, 75990-007-28, 75990-007-30, 75990-007-55
  • Packager: Certus Medical, Inc.
  • 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 25, 2011

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

  • Drug Facts Box OTC-Active Ingredient Section

    Ethyl Alcohol 62% v/v

  • Drug Facts Box OTC-Purpose Section


  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

    if hands are visibly soiled, use regular soap and water

    recommended for repeated use

  • Drug Facts Box OTC-Warnings Section

    FLAMMABLE, keep away from fire and flames

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

  • Drug Facts Box OTC-Keep Out of Reach of Children Section

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

  • Drug Facts Box OTC-Dosage & Administration Section

     apply to hands and rub lightly until dry without wiping or rinsing

  • Drug Facts Box OTC-Inactive Ingredient Section

    water, DEA-C8-18 perfluoroalkylethyl phosphate, propylene glycol

  • Celox Ultra 6968 1000ml bag

    6968M8PM.jpg  Celox Ultra 1000 ml  image of bag label

    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75990-007
    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
    WATER (UNII: 059QF0KO0R)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75990-007-061 in 1 BOX
    1800 mL in 1 BAG
    2NDC:75990-007-30473 mL in 1 BOTTLE, PLASTIC
    3NDC:75990-007-24118 mL in 1 BOTTLE, PLASTIC
    4NDC:75990-007-011200 mL in 1 CARTRIDGE
    5NDC:75990-007-03350 mL in 1 CARTRIDGE
    6NDC:75990-007-05540 mL in 1 BOTTLE, PLASTIC
    7NDC:75990-007-07700 mL in 1 BAG
    8NDC:75990-007-092000 mL in 1 CARTRIDGE
    9NDC:75990-007-101000 mL in 1 CARTRIDGE
    10NDC:75990-007-111000 mL in 1 BOTTLE, PLASTIC
    11NDC:75990-007-121000 mL in 1 BAG
    12NDC:75990-007-13800 mL in 1 BAG
    13NDC:75990-007-143785 mL in 1 BOTTLE, PLASTIC
    14NDC:75990-007-15946 mL in 1 BOTTLE, PLASTIC
    15NDC:75990-007-28149 mL in 1 BOTTLE, PLASTIC
    16NDC:75990-007-27800 mL in 1 CARTRIDGE
    17NDC:75990-007-55208200 mL in 1 DRUM
    18NDC:75990-007-081 in 1 BOX
    181000 mL in 1 BAG
    19NDC:75990-007-16236 mL in 1 BOTTLE, PLASTIC
    20NDC:75990-007-1850 mL in 1 BOTTLE, PLASTIC
    21NDC:75990-007-17532 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/25/2011
    Labeler - Certus Medical, Inc. (966433653)
    Registrant - ABC Compounding Co., Inc. (003284353)
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture