EYS-ED- carboxymethylcellulose sodium 0.5% solution/ drops 
Eyes-Plus LLC

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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Eys Lubricant Eye Drops Single Use

Active ingredient Purpose

Carboxymethylcellulose sodium 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.

Warnings

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 condtion 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.

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.

Distributed by:

Eys Plus LLC

Lomita, CA 90717'

Made in Korea

eysplus

EYS-ED 
carboxymethylcellulose sodium 0.5% solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57349-397
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57349-397-045 in 1 BOX06/13/2018
10.4 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/13/2018
Labeler - Eyes-Plus LLC (078751656)
Registrant - Eyes-Plus LLC (078751656)

Revised: 6/2018
Document Id: 6e8d6f5a-4d56-66e8-e053-2991aa0a553c
Set id: 6e8d6f5a-4d55-66e8-e053-2991aa0a553c
Version: 1
Effective Time: 20180613
 
Eyes-Plus LLC