RxNorm Names

Review RxNorm Normal Forms

REFRESH OPTIVE (carboxymethylcellulose sodium and glycerin) solution/ drops
[Allergan, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f8d88af-fd3b-4138-af61-f24c59ccebd7

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 0.9%

Purpose

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 or becomes cloudy, 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.
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; and sodium citrate dihydrate.

Questions or comments?

Telephone 1.800.433.8871
M-F 6 AM - 4:30 PM
Pacific Time
refreshbrand.com

Refresh
Optive®
Lubricant Eye Drops

Advanced dual action
formula that lubricates
and hydrates dry eyes

MOISTURIZING DRY EYE SOLUTION

0.5 fl oz (15 mL) Sterile

REFRESH OPTIVE
carboxymethylcellulose sodium and glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0023-3240
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carboxymethylcellulose sodium (carboxymethylcellulose)	carboxymethylcellulose sodium	5 mg in 1 mL
glycerin (glycerin)	glycerin	9 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
boric acid
calcium chloride
erythritol
levocarnitine
magnesium chloride
potassium chloride
water
sodium chlorite
sodium chlorate
chlorine dioxide
sodium borate
trisodium citrate dihydrate

Packaging
#	Item Code	Package Description
1	NDC:0023-3240-03	1 in 1 CARTON
1		3 mL in 1 BOTTLE, DROPPER
2	NDC:0023-3240-10	2 in 1 CARTON
2		5 mL in 1 BOTTLE, DROPPER
3	NDC:0023-3240-15	1 in 1 CARTON
3		15 mL in 1 BOTTLE, DROPPER
4	NDC:0023-3240-01	2 in 1 CARTON
4		15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/06/2006

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Business Operations
Allergan, Inc.		362898611	MANUFACTURE(0023-3240)

Revised: 06/2012

Document Id: 6fd4509b-cd07-4fdb-a931-e019d810784f

Set id: 7f8d88af-fd3b-4138-af61-f24c59ccebd7

Version: 3

Effective Time: 20120627

Allergan, Inc.

Daily Med

Current Medication Information

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