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

  • NDC Code(s): 24208-450-15, 24208-450-90
  • Packager: Bausch & Lomb Incorporated
  • 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 August 17, 2023

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  • Active ingredients

    Hypromellose (0.5%)
    Naphazoline hydrochloride (0.03%)

  • Purpose

    Lubricant
    Redness reliever

  • Uses

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

    For external use only

    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.

  • Directions

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

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

    benzalkonium chloride, boric acid, edetate disodium, sodium borate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

  • Questions or comments?

    [phone icon] Call: 1-800-553-5340

  • Package/Label Principal Display Panel

    carton

    BAUSCH + LOMB
    ADVANCED
    Eye Relief®
    Maximum
    Redness
    REDNESS RELIEVER/
    LUBRICANT EYE DROPS

    •
    Maximum strength redness reliever
    •
    Moisturizes and comforts

    STERILE 0.5 FL OZ (15 mL)

    3843902
    AB55411A

  • INGREDIENTS AND APPEARANCE
    ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF 
    naphazoline hydrochloride and hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-450
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED5 mg  in 1 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-450-151 in 1 CARTON09/02/2010
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:24208-450-902 in 1 CARTON07/31/202207/31/2022
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/02/2010
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(24208-450)
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