REFRESH REDNESS RELIEF- phenylephrine hydrochloride and polyvinyl alcohol solution/ drops
Allergan, Inc.

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 REDNESS RELIEF

Drug Facts

Active ingredients

Phenylephrine HCI 0.12%

Polyvinyl Alcohol 1.4%

Purpose

Redness reliever

Eye lubricant

Uses

Relieves redness of the eye due to minor eye irritations.
For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings

For external use only.
Overuse of this product may produce increased redness of the eye.
When using this product pupils may become enlarged temporarily.

Ask a doctor before use if you have narrow angle glaucoma.

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.

To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
Do not use if solution changes color or becomes cloudy.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Other information

Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
Not for use while wearing soft contact lenses.
Use before expiration date marked on container.
Store at 59°-86°F (15°-30°C).
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Benzalkonium chloride; edetate disodium; purified water; sodium acetate; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium thiosulfate. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

1.800.433.8871

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refreshbrand.com

Refresh
Redness Relief®

Redness Reliever and
Lubricant Eye Drops

Moisture drops
for dry, red eyes

0.5 fl oz (15 mL) Sterile

REFRESH REDNESS RELIEF
phenylephrine hydrochloride, polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0023-3414
Route of Administration	OPHTHALMIC	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
phenylephrine hydrochloride (phenylephrine)	phenylephrine hydrochloride	1.2 mg in 1 mL
polyvinyl alcohol (polyvinyl alcohol)	polyvinyl alcohol	14 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium chloride
edetate disodium
water
sodium acetate
sodium phosphate, dibasic
sodium phosphate, monobasic
sodium thiosulfate
hydrochloric acid
sodium hydroxide

#	Item Code	Package Description
Packaging
1	NDC:0023-3414-15	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	05/14/2007	07/26/2014

Labeler - Allergan, Inc. (144796497)

Name	Address	ID/FEI	Business Operations
Establishment
Allergan, Inc.		362898611	MANUFACTURE(0023-3414)

Revised: 4/2011

Document Id: 21e393f3-2ada-4fb8-845b-95bc6ff565cc

Set id: b990b342-4f37-4782-b066-cf6ad696c92a

Version: 2

Effective Time: 20110404

Allergan, Inc.