LEADER LUBRICANT EYE- carboxymethylcellulose sodium solution/ drops 
Cardinal Health

Disclaimer: 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.

----------

Active ingredient                                            Purpose

Carboxymethylcellulose sodium 0.5%............. Eye lubricant

Uses

For external use only.

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 thatn 72 hours.

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

Directions

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

Other information

Inactive ingredients

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

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017

image description

LEADER LUBRICANT EYE 
carboxymethylcellulose sodium solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-032
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-032-301 in 1 BOX
1.04 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/18/2014
Labeler - Cardinal Health (097537435)

Revised: 2/2014
Document Id: a83dc654-73f5-437c-9b0f-e0ff535d05d7
Set id: 7307cea8-7f86-4213-9d5f-9e210e9714bb
Version: 2
Effective Time: 20140218
 
Cardinal Health