Label: FLORIL REDNESS RELIEF - naphazoline hydrochloride solution/ drops

  • NDC Code(s): 16995-001-01, 16995-001-02, 16995-001-03, 16995-001-04
  • Packager: VITALINE S.A.C.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 7, 2010

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  • Actives ingredients Purpose

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

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  • Inactive ingredients

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

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  • 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

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  • 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
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  • 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
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  • KEEP OUT OF REACH OF CHILDREN

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

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  • Use

    Relieves redness of the eye due to minor eye irritations

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  • Directions

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

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  • Other information

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

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  • INGREDIENTS AND APPEARANCE
    FLORIL REDNESS RELIEF 
    naphazoline hydrochloride solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16995-001
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 3 mg  in 10 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH) POLYSORBATE 20 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    LIME (UNII: C7X2M0VVNH) 353 mg  in 10000 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16995-001-01 3 mL in 1 BOTTLE, DROPPER
    2 NDC:16995-001-02 10 mL in 1 BOTTLE, DROPPER
    3 NDC:16995-001-03 15 mL in 1 BOTTLE, DROPPER
    4 NDC:16995-001-04 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 11/10/2005
    Labeler - VITALINE S.A.C. (954343687)
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