REFRESH OPTIVE ADVANCED- carboxymethylcellulose sodium, glycerin, and 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]

SPL UNCLASSIFIED SECTION

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. Replace cap after using.
• 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

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
• Use before expiration date marked on container.
• Discard 90 days after opening.
• Store at 59°-86°F (15°-30°C).
• RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; castor oil; erythritol; levocarnitine; carbomer copolymer type A; purified water; and PURITE® (stabilized oxychloro complex). May also contain sodium hydroxide to adjust pH.

Questions or comments?

1.800.678.1605

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© 2017 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
Revised: June 2, 2017

PRINCIPAL DISPLAY PANEL

Refresh

Optive®

ADVANCED

Lubricant Eye Drops

TRIPLE-ACTION RELIEF

Clinically proven to lubricate,

hydrate, and protect

natural tears from evaporating

0.33 fl oz (10 mL) Sterile

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-4307
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)
castor oil (UNII: D5340Y2I9G)
erythritol (UNII: RA96B954X6)
levocarnitine (UNII: 0G389FZZ9M)
carbomer copolymer type A (UNII: 71DD5V995L)
water (UNII: 059QF0KO0R)
sodium chlorite (UNII: G538EBV4VF)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-4307-03	1 in 1 CARTON	11/30/2011
1		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0023-4307-10	1 in 1 CARTON	11/30/2011
2		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 0023-4307-20	2 in 1 CARTON	11/30/2011
3		10 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	11/30/2011

Labeler - Allergan, Inc. (144796497)