REFRESH REPAIR PRESERVATIVE-FREE- carboxymethylcellulose sodium and glycerin solution/ drops

Refresh Repair Preservative-free by

Drug Labeling and Warnings

Refresh Repair Preservative-free 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 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.
  
• Prior to first use, bottle must be primed. Please read the “Instructions for Use” on the insert inside this carton.
  
• *If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions. 

Other information

• Use only if tape seals on top and bottom flaps are intact.
  
• Use before expiration date marked on container.
  
• Store at 59°-86°F (15°-30°C).   
  
• RETAIN THIS CARTON AND THE INSERT FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; sodium citrate dihydrate; and sodium hyaluronate. May also contain hydrochloric acid and/or sodium hydroxide to adjust ph.

Questions or comments?

HOW SUPPLIED: 0.33 fly oz. (10 ml)                         UPC: 3-0023-6465-10-0
Made in the U.S.A

PRINCIPAL DISPLAY PANEL

Refresh
Repair
Repairs and Protects the
Eye’s Surface; Also Relieves
LASIK Dryness*
NEW!
PRESERVATIVE-FREE
0.33 fl oz. (10 mL) Sterile

PRINCIPAL DISPLAY PANEL

Refresh
Repair
Repairs and Protects the
Eye’s Surface; Also Relieves
LASIK Dryness*
NEW!
PRESERVATIVE-FREE
0.33 fl oz. (10 mL) Sterile
PROFESSIONAL SAMPLE
Not for Retail Sale

INGREDIENTS AND APPEARANCE

REFRESH REPAIR PRESERVATIVE-FREE 
carboxymethylcellulose sodium and glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-6465
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)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
ERYTHRITOL (UNII: RA96B954X6)
LEVOCARNITINE (UNII: 0G389FZZ9M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-6465-10	1 in 1 CARTON	05/02/2019
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0023-6465-11	1 in 1 CARTON	05/02/2019
2		10 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	05/02/2019

Labeler - Allergan, Inc. (144796497)