Label: LUBRICANT / REDNESS RELIEVER- naphazoline hydrochloride and hypromellose solution/ drops

  • 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 December 4, 2018

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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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