Label: CVS GENTLE TEARS- dextran 70, hypromellose liquid

  • Category: HUMAN OTC DRUG LABEL

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 1, 2020

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  • Active ingredients

    Dextran 70 0.1%

    Hypromellose 0.3%

  • Purposes

    Lubricant

    Lubricant

  • Use

    • temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • Warnings

    For external use only

    Do not use

    • if this 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
    • do not reuse
    • once opened, discard

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

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

    store at 15°-25°C (59°-77°F)

  • Inactive ingredients

    boric acid, disodium edetate hydrate, potassium chloride, purified water, sodium borate, sodium chloride

  • CVS Gentle Tears 35ct

    CVS Gentle Tears 35ct

  • INGREDIENTS AND APPEARANCE
    CVS GENTLE TEARS 
    dextran 70, hypromellose liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-474
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.1 g  in 100 mL
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-474-0135 in 1 BOX01/01/2020
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/01/2020
    Labeler - CVS Pharmacy, Inc. (062312574)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460pack(69842-474) , label(69842-474)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed689852052manufacture(69842-474)
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