SODIUM CHLORIDE HYPERTONICITY- sodium chloride solution

Sodium Chloride Hypertonicity by

Drug Labeling and Warnings

Sodium Chloride Hypertonicity by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium chloride 5%

Purpose

Hypertonicity agent

Uses

temporary relief of corneal edema

Warnings

For external use only

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 1-866-767-9161

Package/Label Principal Display Panel

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Compare to the
active ingredient
in Muro 128 ®*
NDC 69842-284-15

Sodium
Chloride
Hypertonicity
ophthalmic solution, 5%
Temporary relief
of corneal edema

Actual Size Bottle
on Side Panel

STERILE

15 mL (0.5 FL OZ)

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE HYPERTONICITY 
sodium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-284
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, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-284-15	1 in 1 CARTON	05/01/2021
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 Drug	M018	05/01/2020

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	manufacture(69842-284)