Label: ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF- naphazoline hydrochloride and hypromelloses 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%)

    Close
  • Purpose

    Lubricant

    Redness reliever

    Close
  • Uses

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

    Keep out of reach of children.

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

    Close
  • Directions

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

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

    Close
  • 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

    3957300

    AB55411

    Close
  • Package/Label Principal Display Panel

    Advanced Eye Relief Carton Image

    BAUSCH + LOMB

    ADVANCED

    Eye Relief®

    Redness

    Maximum Relief

    REDNESS RELIEVER/LUBRICANT EYE DROPS

    Relieves dry, burning

    and irritated eyes

    Long lasting comfort

    Long lasting comfort

    STERILE 0.5 FL OZ (15mL)

    Close
  • 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
    HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES 0.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    BORIC ACID  
    EDETATE DISODIUM  
    WATER  
    SODIUM BORATE  
    SODIUM CHLORIDE  
    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; Combination Product Type = C112160
    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(24208-450)
    Close