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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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REFRESH OPTIVE Mega-3 (Preservative-free)
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 59°-77°F (15°-25°C).
  • Store vials in pouch until use.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; butylated hydroxyl toluene; carbomer copolymer type A; castor oil; erythritol; flaxseed oil; levocarnitine; polyoxyl 40 stearate; purified water; and trehalose. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1.800.678.1605

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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

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

PRINCIPAL DISPLAY PANEL

VALUE SIZE 60 Vials

PRESERVATIVE-FREE
Refresh
OPTIVE 
MEGA-3®
Lubricant Eye Drops
For Eye Dryness 

with HydroCell™

Moisture-rich Relief
Protects Tears from Evaporating

60 Vials 0.01 fl oz (0.4 mL) each Sterile

VALUE SIZE 60 Vials PRESERVATIVE-FREE Refresh OPTIVE MEGA-3® Lubricant Eye Drops For Eye Dryness with HydroCell™ Moisture-rich Relief Protects Tears from Evaporating 60 Vials 0.01 fl oz (0.4 mL) each Sterile

REFRESH OPTIVE MEGA-3 
carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5773
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 805 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
CASTOR OIL (UNII: D5340Y2I9G)  
ERYTHRITOL (UNII: RA96B954X6)  
LINSEED OIL (UNII: 84XB4DV00W)  
LEVOCARNITINE (UNII: 0G389FZZ9M)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
WATER (UNII: 059QF0KO0R)  
TREHALOSE (UNII: B8WCK70T7I)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0023-5773-055 in 1 BOX05/30/2017
10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:0023-5773-3030 in 1 BOX05/30/2017
20.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/30/2017
REFRESH OPTIVE MEGA-3 
carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-7151
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 805 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
CASTOR OIL (UNII: D5340Y2I9G)  
ERYTHRITOL (UNII: RA96B954X6)  
LINSEED OIL (UNII: 84XB4DV00W)  
LEVOCARNITINE (UNII: 0G389FZZ9M)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
WATER (UNII: 059QF0KO0R)  
TREHALOSE (UNII: B8WCK70T7I)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0023-7151-6060 in 1 BOX06/15/2021
10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/15/2021
Labeler - Allergan, Inc. (144796497)

Revised: 6/2021
Document Id: 2522097a-e4b6-4771-b88f-b207b70367f1
Set id: c5f2b3f2-2071-45bd-a010-67f848bc0233
Version: 4
Effective Time: 20210615
 
Allergan, Inc.