Label: EQUATE RESTORE DUAL LUBRICATING- carboxymethylcellulose sodium, and glycerin 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 March 20, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Caboxymethylcellulose sodium 0.5%..................Eye lubricant

    Glycerin 0.9%......................................................Eye lubricant

  • PURPOSE

    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

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
    • do not use if this solution changes color or becomes cloudy
    • remove contact lenses before using
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • continued redness or irritation of the eyes lasts
    • condition worsens or lasts more than 72 hours
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • instill 1 or 2 drops in the affected eye(s) as needed
    • store between 15-30°C (59-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, calcium chloride, magnesium chloride, potassium chloride, purifed water, sodium borate, sodium citrate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Wal-Mart Stores, Inc.

    Bentonville, AR 72716

    Made in South Korea

  • PRINCIPAL DISPLAY PANEL

    23966

  • INGREDIENTS AND APPEARANCE
    EQUATE RESTORE DUAL LUBRICATING 
    carboxymethylcellulose sodium, and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-239
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-239-151 in 1 CARTON03/01/2018
    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 finalpart34903/01/2018
    Labeler - Walmart (051957769)