SPL v1
SPL
SPL Set ID f3af3709-3109-4d5c-8277-9bdfc3137e0f
Route
OPHTHALMIC
Published
Effective Date 2012-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (50 mg)
Inactive Ingredients
Mineral Oil Lanolin Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2006-03-30

Description

Drug Facts

Purpose

Hypertonicity agent


Medication Information

Purpose

Hypertonicity agent

Description

Drug Facts

Use

for temporary relief of corneal edema.

Section 42229-5

Drug Facts

Section 51945-4

Principal Display Panel Text for Carton Label:

NDC 54868-4698-0

3.5 g

Sodium Chloride Ophthalmic Ointment USP, 5%

Hypertonicity

Eye Ointment

Comparable to MURO 128®

Sterile

Net Wt. 3.5 g (1/8oz.)









Warnings
  • Do not use this product except under the advice and supervision of a doctor.
  • Do not use if bottom ridge of tube cap is exposed
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
  • May cause temporary burning and irritation upon application into the eye.
Directions

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.

Active Ingredient

Sodium Chloride 5%

Other Information
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients

Mineral Oil, Modified Lanolin, Purified Water and White Petrolatum.

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children.

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


Structured Label Content

Use

for temporary relief of corneal edema.

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Principal Display Panel Text for Carton Label:

NDC 54868-4698-0

3.5 g

Sodium Chloride Ophthalmic Ointment USP, 5%

Hypertonicity

Eye Ointment

Comparable to MURO 128®

Sterile

Net Wt. 3.5 g (1/8oz.)









Purpose

Hypertonicity agent

Warnings
  • Do not use this product except under the advice and supervision of a doctor.
  • Do not use if bottom ridge of tube cap is exposed
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
  • May cause temporary burning and irritation upon application into the eye.
Directions

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.

Active Ingredient (Active ingredient)

Sodium Chloride 5%

Other Information (Other information)
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients (Inactive ingredients)

Mineral Oil, Modified Lanolin, Purified Water and White Petrolatum.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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.


Advanced Ingredient Data


Raw Label Data

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