Label: RUGBY CARBOXYMETHYLCELLULOSE SODIUM 0.5% EYE DROPS- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 0536-1386-35, 0536-1386-94
  • Packager: Rugby Laboratories
  • 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 May 11, 2023

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  • Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • Purpose

    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 this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    When using this product

    • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.

    Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye, or if the condition 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 (1-800-222-1222) right away.

  • Directions

    instill 1 to 2 drops in the affected eye(s) as needed

  • Other information

    store at 15°-25°C (59°-77°F)

  • Inactive ingredients

    benzalkonium chloride, boric acid, calcium chloride hydrate (dihydrate), hydrochloric acid**, magnesium chloride, potassium chloride, sodium borate, sodium chloride, sodium hydroxide**, water for injection

    **May contain these ingredients to adjust pH.

  • Questions or comments?

    Call 1-888-527-4276

  • Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 15mL

    Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 15mL

  • Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 2-15mL

    Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 2-15mL

  • INGREDIENTS AND APPEARANCE
    RUGBY CARBOXYMETHYLCELLULOSE SODIUM 0.5% EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1386
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1386-941 in 1 BOX05/11/2023
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0536-1386-352 in 1 BOX05/11/2023
    215 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 finalpart34905/11/2023
    Labeler - Rugby Laboratories (079246066)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
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