LUBRICANT / REDNESS RELIEVER (NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE) SOLUTION/ DROPS [RITE AID CORPORATION]

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LUBRICANT / REDNESS RELIEVER (NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE) SOLUTION/ DROPS [RITE AID CORPORATION]
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NDC 11822-3025-5
Set ID 8ff03df6-32d6-425d-8bd7-838bb6885391
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART349
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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

    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
    •
    serious side effects associated with use of the product may be reported to the phone number provided below
  • 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.

  • Questions?

    Call: 1-866-767-8975

    DISTRIBUTED BY:

    RITE AID, 30 HUNTER LANE

    CAMP HILL, PA 17011

    MADE IN USA

    © RITE AID

    ITEM 302155

    9360900

    LR55411

  • Package/Label Principal Display Panel

    Rite Aid 15mL Max Redness Relief Carton

    RITE AID

    PHARMACY®

    MAXIMUM

    RELIEF

    eye care

    sterile

    eye drops

    lubricant and redness

    reliever eye drops

    REDNESS &

    IRRITATION RELIEF

    hydrates, moisturizes,

    soothes, refreshes & cools

    0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    LUBRICANT / REDNESS RELIEVER 
    naphazoline hydrochloride and hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3025
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE5 mg  in 1 mL
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED0.3 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:11822-3025-51 in 1 CARTON09/02/2010
    115 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 - Rite Aid Corporation (014578892)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(11822-3025)
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