Label: NATURES TEARS- hypromellose 2910 (3 mpa.s) solution/ drops 

  • Label RSS
  • NDC Code(s): 0536-6237-72
  • Packager: Rugby Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/11

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

  • Active ingredient

    Hypromellose 0.4%

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  • Purpose

    Lubricant

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  • Uses

    • relieves dryness of the eye
    • prevents further irritation
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  • Warnings

    Do not use if solution changes color or becomes cloudy

    When using this product  

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after use

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists for more than 72 hours
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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

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

    • store at 15° - 30°C (59° - 86°F)
    • keep tightly closed

    FOR USE IN THE EYES ONLY

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  • Inactive ingredients

    dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

    potassium chloride, sodium chloride, purified water.

    Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

    PRESERVATIVE ADDED: benzalkonium chloride 0.01%

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  • Questions or comments?

    Call 1-800-645-2158

    9 am - 5 pm ET, Monday-Friday.

    Serious side effects associated with use of this product may be reported to this number.

    Rugby ®

    Duluth, GA 30097

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  • Package/Label Principal Display Panel

    Carton

    NDC 0536-6237-72

    Rugby®

    COMPARED TO INDICATIONS IN TEARS NATURALE®

    Nature's Tears

    Hypromellose 0.4%

    Lubricant

    Eye Drops

    STERILE

    Rugby®

    1/2 fl oz (15 mL)

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  • INGREDIENTS AND APPEARANCE
    NATURES TEARS 
    hypromellose solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-6237
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYPROMELLOSE 2910 (3 MPA.S) (HYPROMELLOSES) HYPROMELLOSE 2910 (3 MPA.S) 4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC  
    EDETATE DISODIUM  
    SODIUM PHOSPHATE, MONOBASIC  
    POTASSIUM CHLORIDE  
    SODIUM CHLORIDE  
    WATER  
    BENZALKONIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-6237-72 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 10/07/2011
    Labeler - Rugby Laboratories Inc. (109178264)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 196603781 MANUFACTURE
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