Label: EQUATE SUPPORT ADVANCED LUBRICATING EYE- polyethylene glycol 400 and propylene glycol 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 February 15, 2018

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Equate

    Support Advanced Lubricating Eye Drops

    49035-882-54

                                                   

    Drug Facts

  • Active ingredients

    Polyethylene Glycol 400 0.4%

    Propylene Glycol 0.3%

  • Purpose

    Lubricant

    Lubricant

  • Uses

    ● For the temporary relief of burning and irritation due to dryness of the eye.

  • Warnings

    ● For use in the eye(s) only. ● Retain outer carton for full product drug facts.

    Do not use

    ● if twist top of single-use container is broken.

    ● if solution changes color or becomes cloudy.

    ● if you are sensitive to any ingredient in this product.

    When using this product

    ● avoid contamination, do not touch tip of container to any surface.

    ● Do not reuse. Once opened discard.

     Stop use and ask a doctor if

    ● you experience eye pain, changes in vision, continued redness or

       irritation of the eye.

    ● the condition worsens or persists more than 72 hours.

    Keep this and all drugs out of the reach of children.

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

  • Directions

    ● To open, COMPLETELY TWIST OFF TAB.

    ● Instill 1 or 2 drops in the affected eye(s) as needed, and discard container.

  • Other Information

    ● Store at room temperature 15º-30ºC (59º-86F).

  • Inactive ingredients

    Aminomethylpropanol, boric acid, gellan gum, magnesium chloride hexahydrate, potassium chloride, purified water, sodium chloride, sorbitol.

    May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-882-54
    equate
    Support Advanced
    Lubricating Eye
    Drops
    Sterile
    25 Single-Use Containers
    0.02 FL OZ (0.6mL) EACH

    PRINCIPAL DISPLAY PANEL NDC 49035-882-54 equate Support Advanced Lubricating Eye Drops Sterile 25 Single-Use Containers 0.02 FL OZ (0.6mL) EACH

                                                               

                                                         

  • INGREDIENTS AND APPEARANCE
    EQUATE SUPPORT ADVANCED LUBRICATING EYE 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-882
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BORIC ACID (UNII: R57ZHV85D4)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-882-5425 in 1 CARTON05/12/2017
    10.6 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34905/12/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Altaire Pharmaceuticals, Inc. (786790378)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!