Label: ARTIFICIAL TEARS- glycerin solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 28, 2024

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  • Active ingredients

    Glycerin 0.2%

    Hypromellose 0.2%

    Polyethylene glycol 400 1%

  • Purpose

    Lubricant

  • Uses

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

    For external use only

    Do not use this product if solution changes color or becomes cloudy

  • WHEN USING

    When using this product

    •
    to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
    •
    remove contact lenses before using
  • STOP USE

    Stop use and ask a doctor if you experience

    •
    eye pain
    •
    changes in vision
    •
    continued redness or irritation of the eye, or if the condition worsens or persists for 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 (1-800-222-1222) right away.

  • Directions

    •
    instill 1 or 2 drops in the affected eye(s) as needed
    •
    children under 6 years of age: ask a doctor
  • Other information

    •
    store at 15°-30°C (59°-86°F)
  • Inactive ingredients

    benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

  • Questions or comments?

    1-800-540-3765

  • package label

    Artifical Tears Lubricand Eye Drops
  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7266(NDC:57896-181)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.002 mg  in 1 mg
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED0.002 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
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-7266-01 in 1 CARTON03/11/2021
    115 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugMO1803/11/2021
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7266)
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