Label: REVITAL EYES- polyethylene glycol 400 and 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 August 28, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Polyethylene Glycol 400 0.4%Lubricant
    Propylene Glycol 0.3%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 solution 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 feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts 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

    Aminomethylpropanol, boric acid, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    1-800-980-6551

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Lunovus, LLC
    729 1st Ave N,
    Birmingham AL 35203

  • PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

    EXCLUSIVE
    3 PACK
    VALUE 50% MORE!

    RevitalEyes
    Refreshing Eye Drops

    Ultra-High Performance Lubricant Eye Drops

    ✓
    Preservative
    Free
    ✓
    Sterile
    ✓
    Moisturizing
    ✓
    Relieving
    ✓
    Soothing

    Compares to Systane® Ultra Active Ingredients‡
    3 x 0.5 FL OZ (15ml)

    PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    REVITAL EYES 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73197-001
    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 1 mL
    Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Boric Acid (UNII: R57ZHV85D4)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73197-001-013 in 1 CARTON01/01/2020
    115 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 FINALpart34901/01/2020
    Labeler - Lunovus, LLC (166987656)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excite Pharma Services - Tonganoxie KS069731710MANUFACTURE(73197-001) , LABEL(73197-001) , PACK(73197-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excite Pharma Services -- Lee's Summit, MO961636367ANALYSIS(73197-001)
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