EYE LUBRICANT (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) LIQUID [H E B]

EYE LUBRICANT (POLYETHYLENE GLYCOL, PROPYLENE GLYCOL) LIQUID [H E B]
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NDC 37808-637-05
Set ID e019455a-e7b2-4fab-9783-642e321545e1
Category HUMAN OTC DRUG LABEL
Packager H E B
Generic Name
Product Class
Product Number
Application Number PART349
  • Active ingredients

    Polyethylene Glycol 400

    Propylene Glycol

  • Purpose

    Lubricant

    Lubricant

  • Uses

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

    For external use only

    Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor if

    you experience any of the following:

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • condition worsens or persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake well before using
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    benzalkonium chloride, boric acid, hydrochloric acid, hypromellose, potassium chloride, sodium chloride, sodium hydroxide, water

  • Package label

    carton

  • INGREDIENTS AND APPEARANCE
    EYE LUBRICANT 
    polyethylene glycol, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-637
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 15 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-637-0515 mL in 1 BOTTLE; Type 0: Not a Combination Product12/11/2012
    2NDC:37808-637-011 in 1 BOX12/07/2020
    215 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 finalpart34912/05/2012
    Labeler - H E B (007924756)

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