SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC- sodium chloride ointment 
Rugby Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Sodium chloride 50 mg (5%)

Purpose

Hypertonicity agent

Uses

temporary relief of corneal edema

Warnings

For external use only

Do not use except 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%

 
STERILE NET WT. 1/8 OZ. (3.5 G)
carton
SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 
sodium chloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1253
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1253-911 in 1 CARTON11/06/2020
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/06/2020
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(0536-1253)

Revised: 11/2021
Document Id: d67c8b34-5245-49ab-925d-dc95629156d9
Set id: 7546770d-bc12-44b8-9fe0-fc3f5e1d12d1
Version: 2
Effective Time: 20211122
 
Rugby Laboratories