REFRESH OPTIVE DROPS- carboxymethylcellulose sodium and glycerin solution/ drops

REFRESH OPTIVE Drops by

Drug Labeling and Warnings

REFRESH OPTIVE Drops 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 1%

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. 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; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE (stabilized oxychloro complex); sodium borate ® decahydrate; sodium citrate dihydrate.

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Refresh
Optive®

GEL DROPS

Lubricant Eye Gel

EXTENDED THERAPY

Quick, soothing coverage
delivers moisture day or night

0.33 fl oz (10 mL) Sterile

INGREDIENTS AND APPEARANCE

REFRESH OPTIVE DROPS 
carboxymethylcellulose sodium and glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-5459
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	carboxymethylcellulose sodium	10 mg  in 1 mL
glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX)	glycerin	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
sodium chlorite (UNII: G538EBV4VF)
boric acid (UNII: R57ZHV85D4)
sodium borate (UNII: 91MBZ8H3QO)
trisodium citrate dihydrate (UNII: B22547B95K)
potassium chloride (UNII: 660YQ98I10)
calcium chloride (UNII: M4I0D6VV5M)
magnesium chloride (UNII: 02F3473H9O)
erythritol (UNII: RA96B954X6)
levocarnitine (UNII: 0G389FZZ9M)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-5459-10	1 in 1 CARTON	09/30/2015
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0023-5459-02	1 in 1 CARTON	09/30/2015
2		2 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	09/30/2015

Labeler - Allergan, Inc. (144796497)