Label: ORIGINAL REDNESS RELIEVER- naphazoline hydrochloride and polyethylene glycol 300 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 October 1, 2014

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  • Active ingredients

    Naphazoline Hydrochloride (0.012%)

    Polyethylene Glycol 300 (0.2%)

  • Purpose

    Redness reliever

    Lubricant

  • Uses

    •
    Relieves redness of the eye due to minor eye irritations.
    •
    Temporary relief of burning and irritation due to dryness of the eye.
    •
    Protects against 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 302153

    9360700

    LR55811

  • Package/Label Principal Display Panel

    Rite Aid15mL Instant Redness Relief

    RITE

    AID®

    PHARMACY

    INSTANT RELIEF

    eye care

    sterile

    eye drops

    redness reliever and

    lubricant eye drops

    REDNESS RELIEF

    fast acting formula for

    irritated eyes

    refreshes, moisturizes

    and comforts

    0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    ORIGINAL REDNESS RELIEVER 
    naphazoline hydrochloride and polyethylene glycol 300 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3215
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.1 mg  in 1 mL
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) (POLYETHYLENE GLYCOL 300 - UNII:5655G9Y8AQ) POLYETHYLENE GLYCOL 3002 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:11822-3215-31 in 1 CARTON
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/13/2010
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(11822-3215)
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