Label: COFIX RX- povidone-iodine antiviral nasal spray liquid

  • 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 14, 2021

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

  • Active Ingredient(s)

    Povidone-Iodine 1.25 % Purpose: Antiviral

  • Purpose

    Antiviral

  • Use

    Antiviral to temporarily prevent viral infection and transmission

  • Warnings

    Ask a doctor before use if you have
    ■ had nose ulcers or nose surgery ■ had a nose injury that has not healed ■ trouble urinating due to an enlarged prostate ■ heart disease ■ thyroid disease ■ high blood pressure ■ diabetes ■ shellfish allergy

  • Do not use

    ■ if allergic to iodine or inactive ingredient(s) ■ in the eyes ■ on children less than 3 years old

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a healthcare professional before use.

  • STOP USE

    Stop use and ask a doctor if symptoms persist or worsen ■ swelling, infection, rash, or fever occurs

  • 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

    ■ Adults and children over 6 years of age: 1 spray in each nostril not more than 3 times in any 24-hour period

    ■ Children under 6 years of age: consult a doctor

    ■ To use shake well, remove cap, spray directly up nostril quickly and firmly. Do not tilt head backward while spraying. Wipe spray nozzle clean and secure cap following use. Do not share applicators.

  • Other information

    protect from freezing and excessive heat ■ store at room temperature ■ may stain clothing ■ avoid contact with jewelry ■ Keep the carton for complete warning and information

  • Inactive ingredients

    carrageenan, gellan gum, polysorbate, purified water, sodium hydroxide, vitamin D3, xylitol

  • Package Label - Principal Display Panel

    10 mL NDC:78299-211-11 10 mL NDC:81906-211-11

  • INGREDIENTS AND APPEARANCE
    COFIX RX 
    povidone-iodine antiviral nasal spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81906-211
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.25 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81906-211-1110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/14/2021
    Labeler - COFIX-RX LLC (118069675)
    Establishment
    NameAddressID/FEIBusiness Operations
    LXR Biotech LLC968357405repack(81906-211) , manufacture(81906-211)