REFRESH Classic by A-S Medication Solutions REFRESH Classic

REFRESH Classic by

Drug Labeling and Warnings

REFRESH Classic by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REFRESH CLASSIC- polyvinyl alcohol, povidone solution/ drops 
A-S Medication Solutions

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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REFRESH Classic

Drug Facts

Active ingredients

Polyvinyl Alcohol 1.4%

Povidone 0.6%

Purpose

Eye lubricant

Eye lubricant

Uses

• For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
• May be used as a protectant against further irritation.

Warnings

• For external use only.
• To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
• Do not touch unit-dose tip to eye.
• If solution changes color or becomes cloudy, do not use.

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

Directions

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other information

• Use only if single-use container is intact.
• Use before expiration date marked on container.
• Store at 59°-86°F (15°-30°C).
• RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

1.800.433.8871

refreshbrand.com

HOW SUPPLIED

Product: 50090-2358

Polyvinyl Alcohol, Povidone

REFRESH CLASSIC 
polyvinyl alcohol, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-2358(NDC: 0023-0506)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	14 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium chloride (UNII: 451W47IQ8X)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-2358-1	30 in 1 CARTON	04/21/2016	04/30/2019
1		.4 mL in 1 VIAL, SINGLE-USE; 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	09/12/1985	04/30/2019

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-2358)

Revised: 1/2020

Document Id: 7109b8d8-fcda-4836-9363-13c91e9636be

34390-5

Set id: 3bf6193c-56db-45ad-844c-58eb8c33cba9

Version: 12

Effective Time: 20200118

 

A-S Medication Solutions