Your browser does not support JavaScript! CARBOXYMETHYLCELLULOSE SODIUM SOLUTION [PROMED EXPORTS PRIVATE LIMITED]
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CARBOXYMETHYLCELLULOSE SODIUM solution
[PROMED EXPORTS PRIVATE LIMITED]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENT

Carboxymethylcellulose sodium (CMC) 0.5% ............... 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. Do not reuse. Once opened, discard.
  • Do not touch unit-dose tip to eye.
  • Do not use if solution changes color or becomes cloudy.

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

  • Use only if single-use container is intact.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

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 DRUG LABELItem Code (Source)NDC:49668-001
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CALCIUM CHLORIDE 
MAGNESIUM CHLORIDE 
POTASSIUM CHLORIDE 
WATER 
SODIUM CHLORIDE 
SODIUM LACTATE 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
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
 
PROMED EXPORTS PRIVATE LIMITED

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