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NDC 24208-0385-56 Muro 128 50 mg/g Details

Muro 128 50 mg/g

Muro 128 is a OPHTHALMIC OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is SODIUM CHLORIDE.

Product Information

NDC	24208-0385
Product ID	24208-385_679c25d1-0010-47a9-9ffb-38c00b037480
Associated GPIs	86804030104205
GCN Sequence Number	007737
GCN Sequence Number Description	sodium chloride OINT. (G) 5 % OPHTHALMIC
HIC3	Q6A
HIC3 Description	OPHTHALMIC PREPARATIONS, MISCELLANEOUS
GCN	31880
HICL Sequence Number	003389
HICL Sequence Number Description	SODIUM CHLORIDE
Brand/Generic	Brand
Proprietary Name	Muro 128
Proprietary Name Suffix	n/a
Non-Proprietary Name	sodium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	50
Active Ingredient Units	mg/g
Substance Name	SODIUM CHLORIDE
Labeler Name	Bausch & Lomb Incorporated
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24208-0385-56 (24208038556)

Pricing Information	N/A
NDC Package Code	24208-385-56
Billing NDC	24208038556
Package	2 TUBE in 1 CARTON (24208-385-56) / 3.5 g in 1 TUBE
Marketing Start Date	2011-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 93fafa27-5031-4d95-b4b8-5574b7204ae2 Details

Active ingredient

Sodium chloride 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 provided below

Inactive ingredients

lanolin, mineral oil, purified water, white petrolatum

Questions or comments?

Call 1-800-553-5340

Package/Label Principal Display Panel

BAUSCH +LOMB

NDC 24208-385-56

Muro 128®

sodium chloride hypertonicity

ophthalmic ointment, 5%

OINTMENT

5%|

Temporary Relief

of Corneal Edema

TWIN

PACK

STERILE

NET WT. 1/4 OZ. (7 g)

TWO 1/8 OZ (3.5 g) Tubes

9758101

AB15899

INGREDIENTS AND APPEARANCE

MURO 128

sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24208-385
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:24208-385-55	1 in 1 CARTON	01/01/2011
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:24208-385-56	2 in 1 CARTON	01/01/2011
2		3.5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:24208-385-01	1 in 1 CARTON	01/01/2011
3		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	01/01/2011

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-385)

Revised: 4/2022

Document Id: 679c25d1-0010-47a9-9ffb-38c00b037480

Set id: 93fafa27-5031-4d95-b4b8-5574b7204ae2

Version: 8

Effective Time: 20220419