Label: EQUATE RESTORE TEARS- carboxymethylcellulose sodium 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

    Restore Tears Drops

    49035-189-49

    Drug Facts

  • Active ingredient

    Carboxymethylcellulose Sodium 0.5%

  • Purpose

    Eye Lubricant

  • Uses

    ● For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.

    ● May be used as a protectant against further irritation.

  • Warnings

    For use in the eyes only.

    ● Retain outer carton for full product drug facts

    Do not use

    ● If solution changes color, or becomes cloudy.

    When using this product

    ● avoid contamination, do not touch tip of container

       to any surface.

    ● replace cap after each use.

    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 for more than 72 hours.

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

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

  • Other Information

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

    ● keep tightly closed.

  • Inactive ingredients

    Boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium borate, sodium chloride, water for injection. Vanish® (Stabilized Peroxycomplex System as a preservative). May also contain hydrochloric acid and or sodium hydroxide to adjust pH.

  • Questions?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-189-49
    equate
    Restore Tears Drops
    LUBRICANT EYE DROPS
    CARBOXYMETHYCELLULOSE SODIUM 0.5%
    Sterile
    2 – 0.5 fl oz (15mL) BOTTLES
    1 FL OZ (30mL) TOTAL

    NDC 49035-189-49 equate Restore Tears Drops LUBRICANT EYE DROPS CARBOXYMETHYCELLULOSE SODIUM 0.5% Sterile 2 – 0.5 fl oz (15mL) BOTTLES 1 FL OZ (30mL) TOTAL

  • INGREDIENTS AND APPEARANCE
    EQUATE RESTORE TEARS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-189
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-189-492 in 1 CARTON04/10/2014
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34904/10/2014
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Altaire Pharmaceuticals, Inc. (786790378)
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