REFRESH RELIEVA PF XTRA- carboxymethylcellulose sodium and glycerin solution/ drops

Refresh Relieva PF Xtra by

Drug Labeling and Warnings

Refresh Relieva PF Xtra 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

• Prior to first use, please read the “Instructions For Use” inside this carton.
  
• Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Use only if tape seals on top and bottom flaps are intact.
  
• Use before expiration date marked on container.
  
• Discard 90 days after opening.
  
• Store at 59°-77°F (15°-25°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; sodium hyaluronate; and trehalose. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

1.800.678.1605

refresheyedrops.com

PRINCIPAL DISPLAY PANEL

NDC: 0023-3782-10

PRESERVATIVE-FREE
Refresh®
RELIEVA® PF
Xtra
Lubricant Eye Drops
With
HydroCell®
Fast-Acting Relief
Hydrates & Protects
Dry, Sensitive Eyes
0.33 fl oz (10 mL) Sterile

INGREDIENTS AND APPEARANCE

REFRESH RELIEVA PF XTRA 
carboxymethylcellulose sodium and glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-3782
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)
TREHALOSE (UNII: B8WCK70T7I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-3782-10	1 in 1 CARTON	03/01/2024
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0023-3782-35	1 in 1 CARTON	03/01/2024
2		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 0023-3782-50	1 in 1 CARTON	03/01/2024
3		3.5 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 Drug	M018	03/01/2024

Labeler - Allergan, Inc. (144796497)