REFRESH OPTIVE MEGA-3- carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops

REFRESH Optive Mega-3 by

Drug Labeling and Warnings

REFRESH Optive Mega-3 by is a Otc medication manufactured, distributed, or labeled by Allergan, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 59°-86°F (15°-30°C).
  
• Store vials in pouch until use.
  
• RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; butylated hydroxyl toluene; castor oil; erythritol; flaxseed oil; levocarnitine; pemulen TR-2; polyoxyl 40 stearate; purified water; trehalose. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

1.800.678.1605

refreshbrand.com

PRINCIPAL DISPLAY PANEL

Preservative-free
Refresh
Optive® 
MEGA-3
Lubricant Eye Drops

ENHANCED WITH FLAXSEED OIL

Prevents tear evaporation and restores all

three layers of the tear film damaged by Dry Eye.
30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

INGREDIENTS AND APPEARANCE

REFRESH OPTIVE MEGA-3 
carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-5773
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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CASTOR OIL (UNII: D5340Y2I9G)
ERYTHRITOL (UNII: RA96B954X6)
LINSEED OIL (UNII: 84XB4DV00W)
LEVOCARNITINE (UNII: 0G389FZZ9M)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
WATER (UNII: 059QF0KO0R)
TREHALOSE (UNII: B8WCK70T7I)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	SODIUM HYDROXIDE (UNII: 55X04QC32I)
May contain	HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-5773-05	5 in 1 BOX	05/30/2017
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 0023-5773-30	30 in 1 BOX	05/30/2017
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	05/30/2017

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Business Operations
Allergan Sales, LLC		362898611	MANUFACTURE(0023-5773)