Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 7546770d-bc12-44b8-9fe0-fc3f5e1d12d1
Route
OPHTHALMIC
Published
Effective Date 2021-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (50 mg)
Inactive Ingredients
Lanolin Mineral Oil Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-06

Description

Sodium chloride 50 mg (5%)

Purpose

Hypertonicity agent


Medication Information

Purpose

Hypertonicity agent

Description

Sodium chloride 50 mg (5%)

Uses

temporary relief of corneal edema

Warnings

For external use only

Do not useexcept under the advice and supervision of a doctor

When using this product

  • it may cause temporary burning and irritation
  • replace cap after use
  • to avoid contamination do not touch tip of container to any surface

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
Questions

Call 1-800-645-2158

Directions
  • pull down the lower lid of the affected eye
  • apply a small amount (1/4 inch) of ointment to the inside of eyelid
  • apply every 3 or 4 hours or as directed by a doctor
Active Ingredient

Sodium chloride 50 mg (5%)

Other Information
  • store at 15° - 25°C (59° - 77°F)
  • keep tightly closed
  • DO NOT FREEZE
  • see crimp of tube or carton for Lot Number and Expiration Date
  • do not use if difficult to dispense or visible particles are seen in the product
  • serious side effects associated with use of the product may be reported to the phone number below
Inactive Ingredients

lanolin, mineral oil, purified water, white petrolatum

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

Rugby ®

NDC 0536-1253-91

Sodium Chloride Hypertonicity

Ophthalmic Ointment, 5%

  • STERILE NET WT. 1/8 OZ. (3.5 G)

Structured Label Content

Uses

temporary relief of corneal edema

Purpose

Hypertonicity agent

Warnings

For external use only

Do not useexcept under the advice and supervision of a doctor

When using this product

  • it may cause temporary burning and irritation
  • replace cap after use
  • to avoid contamination do not touch tip of container to any surface

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
Questions

Call 1-800-645-2158

Directions
  • pull down the lower lid of the affected eye
  • apply a small amount (1/4 inch) of ointment to the inside of eyelid
  • apply every 3 or 4 hours or as directed by a doctor
Active Ingredient (Active ingredient)

Sodium chloride 50 mg (5%)

Other Information (Other information)
  • store at 15° - 25°C (59° - 77°F)
  • keep tightly closed
  • DO NOT FREEZE
  • see crimp of tube or carton for Lot Number and Expiration Date
  • do not use if difficult to dispense or visible particles are seen in the product
  • serious side effects associated with use of the product may be reported to the phone number below
Inactive Ingredients (Inactive ingredients)

lanolin, mineral oil, purified water, white petrolatum

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)

Rugby ®

NDC 0536-1253-91

Sodium Chloride Hypertonicity

Ophthalmic Ointment, 5%

  • STERILE NET WT. 1/8 OZ. (3.5 G)

Advanced Ingredient Data


Raw Label Data

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