Sodium Chloride Hypertonicity Ophthalmic Solution, 5%

Sodium Chloride Hypertonicity Ophthalmic Solution, 5%
SPL v2
SPL
SPL Set ID 29175c17-223e-5e92-e063-6294a90a71d2
Route
OPHTHALMIC
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-27

Description

DRUG FACTS Active ingredient Sodium chloride 5%

Purpose

DRUG FACTS Active ingredient Sodium chloride 5%


Medication Information

Purpose

DRUG FACTS Active ingredient Sodium chloride 5%

Description

DRUG FACTS Active ingredient Sodium chloride 5%

Use

temporary relief of corneal edema

Section 51727-6

Boric Acid, Hypromellose Methylparaben, Propylene Glycol, Proplyparaben, purified water and sodium Borate, Sodium Hydroxide, and/or Hydrochloric Acid maybe added to adjust pH.

Section 51945-4

NDC 696180-077-55

Reliable 1 Laboratories

Temporary relief of corneal edema

Compare to Muro 128® active ingredient*

Sodium Chloride Hypertonicity Ophthalmic Solution, 5%

Sterile

0.5 fl oz (15mL)

*This product is not manufactured by Bausch & Lomb, the owner of the registered trademark Muro 128®

Distributed by

Reliable 1 Laboratories LLC

Valley Stream, NY 11580

Reliable1labs.com

Section 55105-1

Hypertonicity agent

Warnings

For external use only

Save box for complete information

Directions

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

Other Information

Other information

  • replace cap after using, and keep tightly closed
  • store upright at 15–30 °C (59–86 °F)
  • remove contact lenses before using
Questions Or Comments?

Questions or comments?

Call 1-516-341-0666

8:30AM-4:30PM

Monday – Friday

When Using This Product

When using this product

  • keep tightly closed
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after use
  • this product may cause temporary burning and irritation on being instilled into the eye.
Active Ingredient & Purpose

DRUG FACTS

Active ingredient

Sodium chloride 5%

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
  • condition worsens or persists
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.


Structured Label Content

Use (USE)

temporary relief of corneal edema

Section 51727-6 (51727-6)

Boric Acid, Hypromellose Methylparaben, Propylene Glycol, Proplyparaben, purified water and sodium Borate, Sodium Hydroxide, and/or Hydrochloric Acid maybe added to adjust pH.

Section 51945-4 (51945-4)

NDC 696180-077-55

Reliable 1 Laboratories

Temporary relief of corneal edema

Compare to Muro 128® active ingredient*

Sodium Chloride Hypertonicity Ophthalmic Solution, 5%

Sterile

0.5 fl oz (15mL)

*This product is not manufactured by Bausch & Lomb, the owner of the registered trademark Muro 128®

Distributed by

Reliable 1 Laboratories LLC

Valley Stream, NY 11580

Reliable1labs.com

Section 55105-1 (55105-1)

Hypertonicity agent

Warnings (WARNINGS)

For external use only

Save box for complete information

Directions (DIRECTIONS)

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

Other Information (OTHER INFORMATION)

Other information

  • replace cap after using, and keep tightly closed
  • store upright at 15–30 °C (59–86 °F)
  • remove contact lenses before using
Questions Or Comments? (Questions or comments?)

Questions or comments?

Call 1-516-341-0666

8:30AM-4:30PM

Monday – Friday

When Using This Product (When using this product)

When using this product

  • keep tightly closed
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after use
  • this product may cause temporary burning and irritation on being instilled into the eye.
Active Ingredient & Purpose (Active ingredient & purpose)

DRUG FACTS

Active ingredient

Sodium chloride 5%

Stop Use and Ask A Doctor If (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
  • condition worsens or persists
Keep Out of Reach of Children (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

All Sections (JSON)