Label: SUNMARK LUBRICATING PLUS- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 49348-329-44
  • Packager: Strategic Sourcing Services LLC
  • 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 November 17, 2022

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  • Active ingredient (in each single-use container)

    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 external use only

    Do not use

    if solution changes color or becomes cloudy

    When using this product

    to avoid contamination

    •
    do not touch tip of container to any surface
    •
    do not reuse
    •
    once opened, discard
    •
    do not touch unit-dose tip to eye

    Stop use and ask a doctor if

    •
    you experience eye pain
    •
    changes in vision occur
    •
    redness or irritation of the eye continues
    •
    redness or irritation of the eye worsens or persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    •
    to open, twist and pull tab to remove
    •
    instill 1 or 2 drops in the affected eye(s) as needed and discard container
  • Other information

    •
    store at 20-25°C (68-77°F)
    •
    RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium lactate solution, water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    sunmark®

    COMPARE TO REFRESH PLUS® ACTIVE INGREDIENT

    lubricating plus

    Carboxymethylcellulose Sodium 0.5%

    Lubricant Eye Drops

    Moisturizing Relief

    Sterile

    PRESERVATIVE FREE

    Actual vial size

    30 Sterile Single-Use Containers

    0.01 FL OZ (0.4 mL) EACH

    lubricating plus image
  • INGREDIENTS AND APPEARANCE
    SUNMARK LUBRICATING PLUS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-329
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-329-446 in 1 CARTON06/06/2013
    15 in 1 POUCH
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/06/2013
    Labeler - Strategic Sourcing Services LLC (116956644)
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