Label: EQUATE COMFORT- carboxymethylcellulose sodium and hypromelloses gel

  • 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

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    EQUATE COMFORT GEL

    49035-197-49

    Drug Facts

  • Active ingredients

    Carboxymethylcellulose Sodium 0.25%

    Hypromellose 0.3%

  • Purpose

    Eye Lubricant

    Eye Lubricant

  • Uses

    ● relieves dryness of the eye(s).

    ● for the temporary relief of discomfort due to minor irritations of the eye from exposure to wind or sun. 

    ● 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 this product 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, citric acid, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride. 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 49035-197-49
    equate
    Comfort Gel
    LUBRICANT EYE GEL
    CARBOXYMETHYCELLULOSE SODIUM 0.25%
    HYPROMELLOSE 0.3%
    Sterile
    2- 0.5 FL OZ (15mL) BOTTLES
    1 FL OZ (30mL) TOTAL

    NDC 49035-197-49 equate Comfort Gel LUBRICANT EYE GEL CARBOXYMETHYCELLULOSE SODIUM 0.25% HYPROMELLOSE 0.3% Sterile 2- 0.5 FL OZ (15mL) BOTTLES 1 FL OZ (30mL) TOTAL

  • INGREDIENTS AND APPEARANCE
    EQUATE COMFORT 
    carboxymethylcellulose sodium and hypromelloses gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-197
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES3 mg  in 1 mL
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    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:49035-197-492 in 1 CARTON04/10/2014
    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 FINALpart34904/10/2014
    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!