REFRESH OPTIVE SINGLE VIAL- carboxymethylcellulose sodium, and glycerin solution/ drops

Refresh Optive Single Vial by

Drug Labeling and Warnings

Refresh Optive Single Vial by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Carboxymethylcellulose sodium 0.5%................Eye Lubricant

Glycerin 0.9%......................................................Eye Lubricant

PURPOSE

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 irritaiton

WARNINGS

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 tip unit-dose to eye
• If solution changes color, do not use.

STOP 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

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

STORAGE AND HANDLING

Other information

• use only if single-use container is intact
• use before expiration date marked on the container
• store at 59°-86°F (15°-30°C)

INACTIVE INGREDIENT

Inactive ingredients

boric acid, calcium chloride, levocarnitine, magnesium chloride, polyethylene glycol 400, potassium chloride, purified water, sodium borate, trisodium citrate dihydrate

DOSAGE & ADMINISTRATION

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REFRESH OPTIVE SINGLE VIAL 
carboxymethylcellulose sodium, and glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-548
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)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SODIUM BORATE (UNII: 91MBZ8H3QO)
LEVOCARNITINE (UNII: 0G389FZZ9M)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-548-04	0.4 mL in 1 VIAL; Type 0: Not a Combination Product	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/02/2017

Labeler - United Exchange Corp. (840130579)