Label: REXALL STERILE ARTIFICIAL TEARS EYE DROPS- glycerin solution

  • 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 June 30, 2013

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  • ACTIVE INGREDIENT

    Active ingredients                                                                              Purpose

    Glycerin 0.2%..................................................................................Lubricant

    Hypromellose 0.2%..........................................................................Lubricant

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

  • PURPOSE

    Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for protection against further irritation
  • WARNINGS

    Warnings for external use only

  • WHEN USING

    When using this product

    • remove contact lenses before use
    • do not use if this solution changes color or becomes cloudy
    • do not touch tip of container or any surface to avoid contamination
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or last 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Directions

    • put 1 to 2 drops in the affected eye(s) as needed.
    • 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°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate.

  • DOSAGE & ADMINISTRATION

    Packaged For:

    Dolgencorp, LLC

    100 Mission Ridge

    Goodlettsville, TN 37072 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    REXALL STERILE ARTIFICIAL TEARS EYE DROPS 
    glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-522
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.002 mg  in 1 mg
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES0.002 mg  in 1 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.01 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    GLYCINE (UNII: TE7660XO1C)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-522-151 in 1 CARTON
    115 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/30/2013
    Labeler - Dolgencorp Inc (068331990)