Label: FLORIL REDNESS RELIEF- naphazoline hydrochloride solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 January 7, 2010

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  • PRINCIPAL DISPLAY PANEL

    Box floril redness relief

  • Actives ingredients Purpose

    Naphazoline Hydrocloride 0,03% redness reliever
    Polysorbate 20 0,24% Lubricant

  • Inactive ingredients

    Benzalkonium chloride, chamomile, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, purified water.

  • WARNINGS

    For external use only

    Ask a doctor before use if you have narrow angle glaucoma

    Do not use if the solution changes color or becomes cloudy

  • WHEN USING

    • do not touch the tip of the container to any surface to avoid contamination
    • replace cap after each use
    • overuse may cause more eye redness
    • pupils may become enlarged temporarily
    • remove contact lenses before using
  • Stop use and ask doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

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

  • Use

    Relieves redness of the eye due to minor eye irritations

  • Directions

    Put 1 to 2 drops in the affected eye(s) up to 4 times daily.

  • Other information

    Store at room temperature 15° to 30° (59° to 86° F).

  • INGREDIENTS AND APPEARANCE
    FLORIL REDNESS RELIEF 
    naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16995-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE3 mg  in 10 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH) POLYSORBATE 202 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIME (UNII: C7X2M0VVNH) 353 mg  in 10000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16995-001-013 mL in 1 BOTTLE, DROPPER
    2NDC:16995-001-0210 mL in 1 BOTTLE, DROPPER
    3NDC:16995-001-0315 mL in 1 BOTTLE, DROPPER
    4NDC:16995-001-0430 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/10/2005
    Labeler - VITALINE S.A.C. (954343687)
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