CARBOXYMETHYLCELLULOSE SODIUM- carboxymethylcellulose sodium solution 
PROMED EXPORTS PRIVATE LIMITED

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.

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ACTIVE INGREDIENT

Carboxymethylcellulose sodium (CMC) 0.5% ............... Eye lubricant

USES

WARNINGS

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

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.

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 hydroxide to adjust pH.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 30 Sterile Single Use Containers


CARBOXYMETHYLCELLULOSE SODIUM (CMC) 0.5%
LUBRICANT EYE DROPS

 
carboxymethylcellulose sodium
 
CARBOXYMETHYLCELLULOSE SODIUM 
carboxymethylcellulose sodium solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49668-001
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:49668-001-0130 in 1 CONTAINER
10.4 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34910/01/2009
Labeler - PROMED EXPORTS PRIVATE LIMITED (650538325)
Establishment
NameAddressID/FEIBusiness Operations
PROMED EXPORTS PRIVATE LIMITED650538325manufacture

Revised: 8/2009
Document Id: 3aba460a-1912-4794-a317-f477af962b40
Set id: 3aba460a-1912-4794-a317-f477af962b40
Version: 1
Effective Time: 20090827
 
PROMED EXPORTS PRIVATE LIMITED