REFRESH OPTIVE ADVANCED- carboxymethylcellulose sodium, glycerin, polysorbate 80 solution/ drops

REFRESH OPTIVE Advanced by

Drug Labeling and Warnings

REFRESH OPTIVE Advanced by is a Otc medication manufactured, distributed, or labeled by Allergan, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

Purpose

Eye lubricant

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, 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 59º-86ºF (15º-30ºC).
• RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide.

Questions or comments?

1.800.678.1605

refreshbrand.com

PRINCIPAL DISPLAY PANEL

PDP

Preservative-free NDC: 0023-4491-30
REFRESH AMERICA
SENDING EYE DROPS TO OUR FIRST RESPONDERS

Refresh
Optive®
ADVANCED
Lubricant Eye Drops

TRIPLE-ACTION RELIEF

Clinically proven to lubricate, hydrate,
and protect natural tears from evaporating

30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

INGREDIENTS AND APPEARANCE

REFRESH OPTIVE ADVANCED 
carboxymethylcellulose sodium, glycerin, polysorbate 80 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-4491
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	carboxymethylcellulose sodium	5 mg  in 1 mL
glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX)	glycerin	10 mg  in 1 mL
polysorbate 80 (UNII: 6OZP39ZG8H) (polysorbate 80 - UNII:6OZP39ZG8H)	polysorbate 80	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
boric acid (UNII: R57ZHV85D4)
carbomer copolymer type A (UNII: 71DD5V995L)
castor oil (UNII: D5340Y2I9G)
erythritol (UNII: RA96B954X6)
levocarnitine (UNII: 0G389FZZ9M)
water (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-4491-05	5 in 1 CARTON	01/15/2013
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 0023-4491-30	30 in 1 CARTON	01/15/2013
2		0.4 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	01/15/2013

Labeler - Allergan, Inc. (144796497)