Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID d5cc6cd1-ddf8-4f5b-a021-204cdda0db94
Route
OPHTHALMIC
Published
Effective Date 2021-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (50 mg)
Inactive Ingredients
Lanolin Mineral Oil Water Petrolatum

Identifiers & Packaging

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

Description

Sodium chloride, 50 mg (5%)

Purpose

Hypertonicity agent


Medication Information

Purpose

Hypertonicity agent

Description

Sodium chloride, 50 mg (5%)

Uses

temporary relief of corneal edema

Warnings

For external use only

Do not use

except under the advice and supervision of a doctor

When using this product

it may cause temporary burning and irritation

replace cap after use

to avoid contamination do not touch tip of container to any surface

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

pull down the lower lid of the affected eye

apply a small amount (1/4 inch) of ointment to the inside of eyelid

apply every 3 or 4 hours or as directed by a doctor

Active Ingredient

Sodium chloride, 50 mg (5%)

Other Information

store at 15°-25°C (59°-77°F)

keep tightly closed

▪ DO NOT FREEZE

see crimp of tube or carton for Lot Number and Expiration Date

do not use if difficult to dispense or visible particles are seen in the product

serious side effects associated with use of the product may be reported to the phone number below

Inactive Ingredients

lanolin, mineral oil, purified water, white petrolatum

Keep Out of Reach of Children.

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

Package/label Principal Display Panel Carton

[heart icon] CVSHealth

Compare to the active

ingredient in Muro 128 ®*

NDC 69842-285-35

Sodium Chloride

Hypertonicity

ophthalmic ointment, 5%

Temporary relief of corneal edema

NET WT 0.125 OZ (3.5 g)

STERILE


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

When using this product

it may cause temporary burning and irritation

replace cap after use

to avoid contamination do not touch tip of container to any surface

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

pull down the lower lid of the affected eye

apply a small amount (1/4 inch) of ointment to the inside of eyelid

apply every 3 or 4 hours or as directed by a doctor

Active Ingredient (Active ingredient)

Sodium chloride, 50 mg (5%)

Other Information (Other information)

store at 15°-25°C (59°-77°F)

keep tightly closed

▪ DO NOT FREEZE

see crimp of tube or carton for Lot Number and Expiration Date

do not use if difficult to dispense or visible particles are seen in the product

serious side effects associated with use of the product may be reported to the phone number below

Inactive Ingredients (Inactive ingredients)

lanolin, mineral oil, purified water, white petrolatum

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 Carton (Package/Label Principal Display Panel - Carton)

[heart icon] CVSHealth

Compare to the active

ingredient in Muro 128 ®*

NDC 69842-285-35

Sodium Chloride

Hypertonicity

ophthalmic ointment, 5%

Temporary relief of corneal edema

NET WT 0.125 OZ (3.5 g)

STERILE


Advanced Ingredient Data


Raw Label Data

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