Drug Labeling and Warnings

Drug Details

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SODIUM CHLORIDE- sodium chloride ophthalmic ointment ointment 
AACE PHARMACEUTICALS, INC.

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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SPL UNCLASSIFIED SECTION

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.

ACTIVE INGREDIENTS

Sodium Chloride 5%

PURPOSE

Hypertonicity agent

USE

For temporary relief of corneal edema.

WARNINGS

  • Do not use this product except under the advice and supervision of a doctor.
  • Do not use if bottom ridge of tube cap is exposed.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
  • May cause temporary burning and irritation upon application into the eye.

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep out of reach of children

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

DIRECTIONS

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.

OTHER INFORMATION

  • Store at 20° to 25°C (68° to 77°F) [ See USP Controlled Room Temperature].

  • Store away from heat.

  • Protect from freezing.

  • Keep tightly closed.

  • See crimp for Lot Number and Expiration Date.

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

INACTIVE INGREDIENTS

Lanolin, Mineral Oil, Purified Water and White Petrolatum.

PRINCIPAL DISPLAY PANEL

NDC#: 71406-123-35

*Compare to MURO 128 ®

Sodium Chloride Opthalmic Ointment USP, 5%

Hypertonicity Eye Ointment

FOR OPTHALMIC USE ONLY

Net Wt. 3.5 g (1/8 oz.) Sterile

Distributed By:

AACE Pharmaceuticals, Inc., Fairfield, NJ 07004

www.aacepharma.com

Rev. 00

MURO 128® is a registered Trademark of Bausch and Lomb Pharmaceuticals, Inc. Tampa, Florida 33637.

carton

SODIUM CHLORIDE 
sodium chloride ophthalmic ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71406-123
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LANOLIN (UNII: 7EV65EAW6H)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71406-123-351 in 1 CARTON03/18/2020
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/18/2020
Labeler - AACE PHARMACEUTICALS, INC. (080630748)
Establishment
NameAddressID/FEIBusiness Operations
AACE Pharmaceuticals, Inc.080630748manufacture(71406-123) , pack(71406-123)

Revised: 3/2020
 
AACE PHARMACEUTICALS, INC.


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