REVITAL EYES- polyethylene glycol 400 and propylene glycol solution/ drops

Revital eyes by

Drug Labeling and Warnings

Revital eyes by is a Otc medication manufactured, distributed, or labeled by Lunovus, LLC, Excite Pharma Services - Tonganoxie KS, Excite Pharma Services -- Lee's Summit, MO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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)

INGREDIENTS AND APPEARANCE

REVITAL EYES 
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73197-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	4 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73197-001-01	3 in 1 CARTON	01/01/2020
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	01/01/2020

Labeler - Lunovus, LLC (166987656)

Establishment
Name	Address	ID/FEI	Business Operations
Excite Pharma Services - Tonganoxie KS		069731710	MANUFACTURE(73197-001) , LABEL(73197-001) , PACK(73197-001)

Establishment
Name	Address	ID/FEI	Business Operations
Excite Pharma Services -- Lee's Summit, MO		961636367	ANALYSIS(73197-001)