Label: MAXIMUM REDNESS RELIEF EYE- glycerin, naphazoline hcl 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 6, 2019

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  • ACTIVE INGREDIENT

    ​Active ingredients

    Glycerin 0.5%

    Naphazoline hydrochloride 0.03%

  • PURPOSE

    ​Purpose

    Glycerin...Lubricant

    Naphazoline hydrochloride...Redness reliever

  • INDICATIONS & USAGE

    Uses

    • For the relief of redness of the eye due to minor eye irritations
    • For the temporary relief of burning and irritation due to dryness of the eye
    • For use as a protectant against further irritation or dryness of the eye
  • WARNINGS

    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

    • To avoid contamination, do not touch tip of container to any surface
    • Replace cap after using
    • Overuse may produce increased redness of the eye
    • Pupils may become enlarged temporarily

    Stop use and ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Instill 1 or 2 drops in the affected eye(s) up to four times daily.

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature
    • remove contact lenses before using
    • Tamper Evident: Do not use this product if imprinted neckband is missing or broken
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    MAXIMUM REDNESS RELIEF EYE 
    glycerin, naphazoline hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-285
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN500 mg  in 100 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE30 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-285-151 in 1 BOX01/09/2015
    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 finalpart34901/09/2015
    Labeler - WinCo Foods, LLC (056098817)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(67091-285) , label(67091-285) , pack(67091-285)
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