Label: ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF- naphazoline hydrochloride and hypromellose solution/ drops

  • NDC Code(s): 24208-450-15
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/10

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

  • Active Ingredients

    Hypromellose (0.5%)

    Naphazoline hydrochloride (0.03%)

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  • Purpose

    Lubricant

    Redness reliever

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  • Uses

    • temporary relief of redness and discomfort due to:
      • minor eye irritations
      • exposure to wind or sun
      • dryness of the eye
    • prevents further irritation
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  • Warnings

    Do not use

    • if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    • narrow angle glaucoma

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • do not overuse as it may produce increased redness of the eye
    • pupils may become enlarged temporarily
    • remove contact lenses before using
    • replace cap after use

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists for more than 72 hours

    Keepout of reach of children.

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

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  • Directions

    • instill 1 to 2 drops in the affected eye(s) up to four times daily
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  • Other information

    • store at 15°-25°C (59°-77°F)
    • keep tightly closed
    • use before expiration date marked on the carton and bottle
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  • Inactive ingredients

    benzalkonium chloride (0.01%), boric acid, edetate disodium, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

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  • Questions or Comments?

    Toll Free Product Information or to Report a Serious Side Effect Associated with use of this product Call: 1-800-553-5340

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  • Package/Label Principal Display Panel

    Bausch & Lomb AER Redness carton

    Bausch & Lomb

    Advanced Eye Relief™

    Redness

    Maxium Relief

    Redness Reliever/Lubricant Eye Drops

    Relieves dry, burning and irritated eyes

    Long lasting comfort

    0.5 FL OZ (15mL)

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  • INGREDIENTS AND APPEARANCE
    ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF 
    naphazoline hydrochloride and hypromellose solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24208-450
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 5 mg  in 1 mL
    HYPROMELLOSE (HYPROMELLOSE) HYPROMELLOSE 0.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    BORATE ION  
    SODIUM BORATE  
    SODIUM CHLORIDE  
    WATER  
    EDETATE DISODIUM  
    HYDROCHLORIC ACID  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-450-15 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 09/02/2010
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 114406598 MANUFACTURE
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