SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC- sodium chloride ointment

Sodium Chloride Hypertonicity Ophthalmic by

Drug Labeling and Warnings

Sodium Chloride Hypertonicity Ophthalmic by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium chloride 50 mg (5%)

Purpose

Hypertonicity agent

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

Keep Out of Reach of Children

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

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

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

Questions[phone icon]

Call 1-800-645-2158

Package/Label Principal Display Panel Carton

Rugby®

NDC: 0536-1253-91

Sodium Chloride Hypertonicity
Ophthalmic Ointment, 5%

1. STERILE NET WT. 1/8 OZ. (3.5 G)

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 
sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1253
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1253-91	1 in 1 CARTON	11/06/2020
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	11/06/2020

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		079587625	manufacture(0536-1253)