Label: GREEN GUARD LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution

  • NDC Code(s): 47682-194-83
  • Packager: UniFirst First Aid Corporation
  • 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 October 24, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • PURPOSE

    Purpose

    Eye lubricant

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
    • for use a protectant against further irritation

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if solution changes color or becomes cloudy
  • WHEN USING

    When using this product

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

    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

    Keep out od reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • to open, twist and pull tab to remove
    • instill 1 or 2 drops in the affected eye(s) as needed and discard container
    • if used for post-operative (e.g.,LASIK) dryness and discomfort, follow your eye doctor's instructions
  • OTHER SAFETY INFORMATION

    Other information

    • store at 59º-77ºF (15º-25ºC)
    • use only if single-use container is intact
    • use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • INACTIVE INGREDIENT

    Inactive ingredients

    calcium chloride, **hydrochloric acid, magmesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate

    ** May contain these ingredients to adjust pH

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • PRINCIPAL DISPLAY PANEL

    Preservative-free

    Lubricant eye drops

    NDC 47682-194-84

    *Compare to the active ingredients in Refresh Plus®

    Carboxymethylcellulose Sodium 0.5% Eye Lubricant

    Immediate, long-lasting relief for dry, irritated eyes

    Green Guard

    Sterile

    30 Single-Use Containers

    0.01 fl oz (0.4 mL) each

    Lubricant

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-194
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-194-8330 in 1 BOX09/01/2021
    10.4 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/01/2021
    Labeler - UniFirst First Aid Corporation (832947092)
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