Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 9245d842-7f78-42d8-83ba-8eb9ec8dbc0d
Route
OPHTHALMIC
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (50 mg)
Inactive Ingredients
Boric Acid Hypromellose, Unspecified Propylene Glycol Water Sodium Borate Hydrochloric Acid Sodium Hydroxide Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-01

Description

Sodium chloride 5%

Purpose

Hypertonicity agent


Medication Information

Purpose

Hypertonicity agent

Description

Sodium chloride 5%

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

Questions

[phone icon] Call 1-866-767-9161

Directions

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

Active Ingredient

Sodium chloride 5%

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%.

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

[heart icon] CVS

Health

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)


Structured Label Content

Uses

temporary relief of corneal edema

Purpose

Hypertonicity agent

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

Questions

[phone icon] Call 1-866-767-9161

Directions

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

Active Ingredient (Active ingredient)

Sodium chloride 5%

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 (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%.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

[heart icon] CVS

Health

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)


Advanced Ingredient Data


Raw Label Data

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