SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION- sodium chloride solution 
Rugby Laboratories

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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Drug Facts

Active ingredients

Sodium chloride 5%

Purpose

Hypertonicity agent

Uses

temporary relief of corneal edema

Warnings

Do not use

except under the advice and supervision of a doctor
if solution changes color or becomes cloudy

When using this product  

it may cause temporary burning and irritation
to avoid contamination do not touch tip of container to any surface
replace cap after use

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

 
instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.

Other information

store upright at 15° - 25°C (59° - 77°F)
keep tightly closed
serious side effects associated with use of the product may be reported to the phone number provided below

 

Inactive ingredients

boric acid, hypromellose, propylene glycol, purified water, sodium borate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVES ADDED: methylparaben 0.023%, propylparaben 0.01%.

Questions?

[phone icon] Call 1-800-645-2158

Package/Label Principal Display Panel – carton

carton

NDC 0536-1254-94

Rugby®

Sodium Chloride
Hypertonicity
Ophthalmic
Solution, 5%

STERILE

1/2 FL. OZ. (15 mL)

SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION 
sodium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1254
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1254-941 in 1 CARTON09/17/2020
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/17/2020
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(0536-1254)

Revised: 9/2020
Document Id: 822d25c0-71b3-421d-b702-4cded0c4ca32
Set id: 822d25c0-71b3-421d-b702-4cded0c4ca32
Version: 1
Effective Time: 20200917
 
Rugby Laboratories