Label: WALGREEN STERILE LUBRICANT- propylene glycol 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 September 24, 2015

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  • ACTIVE INGREDIENT

    Active ingredient                                               Purpose

    Propylene glycol 0.6%..................................... Lubricant

  • PURPOSE

    Uses

    • For the temporary relief of burning and irritation due to dryness of the eye
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if this product changes color
    • if you are sensitive to any ingredient in this product
  • WHEN USING

    When using this product

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

    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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • Shake well before use.
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • STORAGE AND HANDLING

    Other information

    Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    boric acid, castor oil, methylparaben, polyoxyethylene sorbitan monooleate, potassium chloride, povidone K25, propylparaben, sodium chloride, sodium hydroxide, purified water

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Walgreen Co.

    200 Wilmot Rd.

    Deerfield, IL 60015

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WALGREEN STERILE LUBRICANT 
    propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7864
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.06 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    POVIDONE K25 (UNII: K0KQV10C35)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7864-151 in 1 CARTON
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0363-7864-302 in 1 CARTON
    230 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 finalpart34907/27/2015
    Labeler - Walgreen Company (008965063)
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