Label: MEDICS CHOICE LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution

  • NDC Code(s): 55651-030-01
  • Packager: K.C. Pharmaceuticals, Inc.
  • 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 February 10, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients

    carboxymethylcellulose sodium 0.5%

  • PURPOSE

    Purpose

    Carboxymethylcellulose sodium......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
    • may be used as a protectant against further irritation
  • WARNINGS

    Warnings

    For external use only

    Do not use this product if

    • solution changes color or becomes cloudy

    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 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 the 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 yur eye doctor's instructions
  • OTHER SAFETY INFORMATION

    Other information

    • store at 15º-25ºC (59º-77ºF)
    • 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, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate.

    **may contain these ingredients to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    CARTON

  • INGREDIENTS AND APPEARANCE
    MEDICS CHOICE LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-030
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55651-030-015 in 1 CARTON02/10/2020
    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 finalpart34902/10/2020
    Labeler - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(55651-030) , pack(55651-030) , label(55651-030)
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!