SPL v2
SPL
SPL Set ID 822d25c0-71b3-421d-b702-4cded0c4ca32
Route
OPHTHALMIC
Published
Effective Date 2020-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (50 mg)
Inactive Ingredients
Boric Acid Hypromellose 2208 (100 Mpa.s) Propylene Glycol Water Sodium Borate Methylparaben Propylparaben Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-17

Description

Sodium chloride 5%

Purpose

Hypertonicity agent


Medication Information

Purpose

Hypertonicity agent

Description

Sodium chloride 5%

Uses

temporary relief of corneal edema

Warnings

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

[phone icon] Call 1-800-645-2158

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

 

Active Ingredients

Sodium chloride 5%

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 – Carton

NDC 0536-1254-94

Rugby ®

Sodium Chloride

Hypertonicity

Ophthalmic

Solution, 5%

STERILE

1/2 FL. OZ. (15 mL)


Structured Label Content

Uses

temporary relief of corneal edema

Purpose

Hypertonicity agent

Warnings

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

[phone icon] Call 1-800-645-2158

Other Information (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

 

Active Ingredients (Active ingredients)

Sodium chloride 5%

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 – Carton (Package/Label Principal Display Panel – carton)

NDC 0536-1254-94

Rugby ®

Sodium Chloride

Hypertonicity

Ophthalmic

Solution, 5%

STERILE

1/2 FL. OZ. (15 mL)


Advanced Ingredient Data


Raw Label Data

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