Label: EQUATE SUPPORT MOISTURE LUBRICANT EYE- 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 January 19, 2018

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  • SPL UNCLASSIFIED SECTION

    Equate 
    Support Moisture Lubricant Eye Drops 
    49035-145-10

    Drug Facts

  • Active ingredients

    Propylene Glycol 0.6%

  • Purpose

    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 solution changes color.

    ● 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.

    ● replace cap after each use.

    ● remove contact lenses.

    Stop use and ask a doctor if

    ● you experience eye pain, changes in vision, continued redness or irritation of the eye(s).

    ● 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 (1-800-222-1222).

  • Directions

    ● Shake well before use.

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

  • Other Information

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

    ● Keep tightly closed.

  • Inactive ingredients:

    Boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, gellan gum, mineral oil, polyhexamethylene biguanide (preservative), polyoxyl 40 stearate, purified water, sodium hydroxide, sorbitan tristearate and sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-145-10

    equate
    Support
    Moisture
    Propylene Glycol 0.6 %
    Sterile
    0.33 FL OZ (10mL)

    PRINCIPAL DISPLAY PANEL NDC 49035-145-10 equate Support Moisture Propylene Glycol 0.6 % Sterile 0.33 FL OZ (10mL)

  • INGREDIENTS AND APPEARANCE
    EQUATE SUPPORT MOISTURE LUBRICANT EYE 
    propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-145
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- (UNII: BI71WT9P3R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    SORBITOL (UNII: 506T60A25R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-145-101 in 1 CARTON02/04/2015
    110 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 FINALpart34902/04/2015
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Altaire Pharmaceuticals, Inc. (786790378)
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