Label: GOODSENSE MAXIMUM STRENGTH REDNESS RELIEF PLUS- glycerin, and naphazoline hydrochloride 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 January 8, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                                        Purpose

    Glycerin 0.5%.........................................................Lubricant

    Naphazoline HCL 0.03%..................................Redness reliever

  • PURPOSE

    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 to relieve dryness of the eye.
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use if solution changes color or becomes cloudy.

  • ASK DOCTOR

    Ask a doctor before use if you have narrow angle glaucoma.

  • WHEN USING

    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

    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
    • symptoms persist for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poision Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • To open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.
    • Put 1 to 2 drops in the affected eye(s) up to four time daily
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature.
    • Remove contact lenses before using.
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Geiss, Destin & Dunn, Inc.

    Peachtree City, GA 30269

    www.valuelabels.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GOODSENSE MAXIMUM STRENGTH REDNESS RELIEF PLUS 
    glycerin, and naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-778
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN.00015 mg  in 1 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE.0025 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-778-051 in 1 BOX
    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 finalpart34901/05/2016
    Labeler - Good Sense (Geiss, destin & dunn, Inc.) (076059836)