SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION- sodium chloride solution

Sodium Chlorode Hypertonicity Ophthalmic Solution by

Drug Labeling and Warnings

Sodium Chlorode Hypertonicity Ophthalmic Solution by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

NDC: 0536-1254-94

Rugby®

Sodium Chloride
Hypertonicity
Ophthalmic
Solution, 5%

STERILE

1/2 FL. OZ. (15 mL)

INGREDIENTS AND APPEARANCE

SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION 
sodium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1254
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1254-94	1 in 1 CARTON	09/17/2020
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/17/2020

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	MANUFACTURE(0536-1254)