SPL v4
SPL
SPL Set ID c7acc338-2b84-4929-9b23-3abc35a3edcd
Route
OPHTHALMIC
Published
Effective Date 2022-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-21

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 Container Label:

RITE

AID®

PHARMACY

eye care

ophthalmic

solution

sodium chloride USP 5%

hypertonicity

eye drops

Sterile

0.5 FL OZ (15 mL)

Questions

call 1-800-579-8327

Directions

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

Do Not Use
  • this product except under the advice and supervision of a doctor.
  • if imprinted seal is broken or missing.
  • if solution changes color or becomes cloudy.
Active Ingredient

Sodium Chloride 5%

Other Information
  • Store at 20° to 25°C (68° to77°F) [see USP Controlled Room Temperature].
  • Keep tightly closed.
Inactive Ingredients

Boric Acid, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylparaben 0.1 mg (0.01%), Propylene Glycol, Sodium Borate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (6.0 to 8.0), and Purified Water USP.

When Using This Product
  • temporary burning and irritation upon being instilled into eye may occur.
  • to avoid contamination, do not touch tip of container to any surface.
  • replace cap after each use.
Stop Use and Ask A Doctor If
  • you experience eye pain.
  • you experience changes in vision.
  • redness or irritation of the eye continues
  • condition worsens or persists.
Keep Out of Reach of Children.

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


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 Container Label:

RITE

AID®

PHARMACY

eye care

ophthalmic

solution

sodium chloride USP 5%

hypertonicity

eye drops

Sterile

0.5 FL OZ (15 mL)

Purpose

Hypertonicity Agent

Questions

call 1-800-579-8327

Directions

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

Do Not Use (Do not use)
  • this product except under the advice and supervision of a doctor.
  • if imprinted seal is broken or missing.
  • if solution changes color or becomes cloudy.
Active Ingredient (Active ingredient)

Sodium Chloride 5%

Other Information (Other information)
  • Store at 20° to 25°C (68° to77°F) [see USP Controlled Room Temperature].
  • Keep tightly closed.
Inactive Ingredients (Inactive ingredients)

Boric Acid, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylparaben 0.1 mg (0.01%), Propylene Glycol, Sodium Borate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (6.0 to 8.0), and Purified Water USP.

When Using This Product (When using this product)
  • temporary burning and irritation upon being instilled into eye may occur.
  • to avoid contamination, do not touch tip of container to any surface.
  • replace cap after each use.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience eye pain.
  • you experience changes in vision.
  • redness or irritation of the eye continues
  • 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 immediately.


Advanced Ingredient Data


Raw Label Data

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