RETAINE CMC LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution

Retaine CMC Lubricant Eye Drops by

Drug Labeling and Warnings

Retaine CMC Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by OCuSOFT Inc., Altaire Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

Uses

• Relieves dryness of the eye.
• Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind or sun.
• As a protectant against further irritation. 
  

Warnings

For use in the eyes only.
Do not use if solution changes color or becomes cloudy.

When using this product

• do not touch tip of container to any surface to avoid contamination.
• do not reuse once opened.
  

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or irritation of the eye.
• the condition worsens or persists for more than 72 hours.

KEEP OUT OF THE REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

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

Other Information

• Use only if printed tamper seals on top and bottom flaps are intact.
  
• Use only if twist top of single-dose container is intact.
• Store between 15º-30ºC (59º-86ºF).
  

Inactive Ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate.  May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions

Call (800) 233-5469 M-F 8:30AM-5:00PM CST or visit www.retainebrand.com

Purpose

Eye Lubricant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RETAINE CMC LUBRICANT EYE DROPS 
carboxymethylcellulose sodium solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54799-897
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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-897-30	30 in 1 CONTAINER	09/01/2011
1		0.4 mL in 1 VIAL, SINGLE-DOSE; 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	09/01/2011

Labeler - OCuSOFT Inc. (174939207)

Establishment
Name	Address	ID/FEI	Business Operations
Altaire Pharmaceuticals, Inc.		786790378	manufacture(54799-897)