822d25c0-71b3-421d-b702-4cded0c4ca32

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

Purpose

Hypertonicity agent

Description

Sodium chloride 5%


Medication Information

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
Uses

temporary relief of corneal edema

Purpose

Hypertonicity agent

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

 

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%.

Description

Sodium chloride 5%

Questions?

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

Active Ingredients

Sodium chloride 5%

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

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
Uses

temporary relief of corneal edema

Purpose

Hypertonicity agent

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

 

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%.

Questions?

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

Active Ingredients (Active ingredients)

Sodium chloride 5%

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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