Label: DG HEALTH ARTIFICAL TEARS- glycerin, hypromellose, and polyethylene glycol 400 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 November 27, 2017

If you are a consumer or patient please visit this version.

  • 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 using
    • do not use if this solution changes color or becomes cloudy
    • do not touch tip of container to 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 eyes last
    • 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • pute 1 or 2 drops in the affected eye(s) as needed
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at 15° to 25° (59° to 77°)
  • 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

    Distributed by:

    Dolgencorp, LLC

    100 Mission Ridge

    Goodlettsville, TN 37072

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DG HEALTH ARTIFICAL TEARS 
    glycerin, hypromellose, and polyethylene glycol 400 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-644
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 mg  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSES2 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40011.28 mg  in 1 mL
    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:55910-644-151 in 1 CARTON02/27/2017
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/27/2017
    Labeler - Dolgencorp Inc. (068331990)