REVITAL EYES- polyethylene glycol 400 and propylene glycol solution/ drops 
Lunovus, LLC

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.

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Revital eyes

Drug Facts

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

Other information

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

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
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)

Revised: 8/2019
Document Id: 4ea83ff8-3c0f-430c-acdc-6edc3dfc293f
Set id: de588218-df1e-41da-b054-cfc170fae4d8
Version: 1
Effective Time: 20190828
 
Lunovus, LLC