Label: GENTEAL TEARS (MILD)- dextran 70 and hypromellose 2910 solution/ drops

  • 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 January 18, 2020

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Dextran 70 0.1%Lubricant
    Hypromellose 2910 0.3%Lubricant
  • Uses

    • temporary relief of burning and irritation due to dryness of the eye
    • temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    • as a protectant against further irritation
  • Warnings

    For external use only

  • Do not use

    • if solution 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

    Stop use and ask a doctor if you experience any of the following:

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • 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 right away.

  • Directions

    • put 1 or 2 drops in the affected eye(s) as needed
  • Other information

    • store at room temperature
  • Inactive ingredients:

    POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium borate and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • HOW SUPPLIED

    Product: 50090-2352

    NDC: 50090-2352-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

  • Questions?

    In the U.S. call 1-800-757-9195
    (Mon-Fri 9AM-5PM CST)
    alcon.medinfo@alcon.com

  • dextran 70 and hypromellose 2910

    Label Image
  • INGREDIENTS AND APPEARANCE
    GENTEAL TEARS (MILD)  
    dextran 70 and hypromellose 2910 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-2352(NDC:0065-0418)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S)3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-2352-01 in 1 CARTON04/14/2016
    115 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 finalpart34903/01/2016
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-2352)
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