REFRESH OPTIVE- carboxymethylcellulose sodium, glycerin solution/ drops

Refresh Optive by

Drug Labeling and Warnings

Refresh Optive 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 0.9%

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, 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.

*lf used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions.

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

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; and sodium citrate dihydrate.

Questions or comments?

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PRINCIPAL DISPLAY PANEL

NDC: 0023-3416-30

Preservative-free

Refresh
Optive®
Lubricant Eye Drops

LONG-LASTING HYDRATION

Lubricating and hydrating formula
penetrates the surface to relieve dryness.
Also recommended for LASIK dryness.*

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

INGREDIENTS AND APPEARANCE

REFRESH OPTIVE 
carboxymethylcellulose sodium, glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-3416
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	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Calcium Chloride (UNII: M4I0D6VV5M)
Erythritol (UNII: RA96B954X6)
Levocarnitine (UNII: 0G389FZZ9M)
Magnesium Chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
water (UNII: 059QF0KO0R)
sodium borate (UNII: 91MBZ8H3QO)
trisodium citrate dihydrate (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-3416-05	5 in 1 CARTON	08/22/2008
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 0023-3416-30	30 in 1 CARTON	08/22/2008
2		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
3	NDC: 0023-3416-60	60 in 1 CARTON	08/22/2008
3		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	08/22/2008

Labeler - Allergan, Inc. (144796497)