CVS REDNESS RELIEF MAXIMUM (DEXTRAN 70 POLYETHYLENE GLYCOL 400 POVIDONE TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [CVS PHARMACY, INC. ]

CVS REDNESS RELIEF MAXIMUM (DEXTRAN 70 POLYETHYLENE GLYCOL 400 POVIDONE TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [CVS PHARMACY, INC. ]
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NDC 59779-731-15
Set ID 5b7768eb-084d-4b18-b6c2-829531184b86
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredients                                     Purpose

    Dextran 70 0.1%.................................... Lubricant

    Polyethylene glycol 400 1%..................... Lubricant

    Povidone 1%.......................................... Lubricant

    Tetrahydrozoline HCI 0.05%..................... Redness Reliever

  • PURPOSE

    Uses

    • for the relief of redness of th eyes due to minor eye irritations
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • WARNINGS

    Warnings

    Ask a doctor before use if you have narrow angle glaucoma

  • WHEN USING

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • to avoid contamination, do not touch tip of container to any surface
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye persists
    • condition worsens or lasts more than 72 hours
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Poision Control Center right away

  • INDICATIONS & USAGE

    Directions

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • store at 15° to 25°C (59° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients:

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    CVS PHARMACY, INC.

    ONE CVS DRIVE

    WOONSOCKET, RI 02895 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CVS REDNESS RELIEF MAXIMUM 
    dextran 70 polyethylene glycol 400 povidone tetrahydrozoline hci solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-731
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.001 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.01 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.01 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.0005 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-731-151 in 1 BOX03/07/2014
    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 finalpart34903/06/2014
    Labeler - CVS Pharmacy, Inc. (062312574)

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