MAJOR HYPERTONICITY OPHTHALMIC- sodium chloride ointment
Major Pharmaceuticals

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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Major Sodium Chloride Hypertonicity Ophthalmic Oint. 0.125oz (48938) 2018

Active ingredient Purpose

Sodium chloride, 50 mg (5%).................Hypertonicity agent

Uses

- temporary relief of corneal edema

Warnings

Do not use

- except under the advice and supervision of a doctor

When using this product

- it may cause temporary burning and irritation

- do not touch tip of container to any surface to avoid contamination

- replace cap after each use

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 (59 - 77)

- 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

Inactive ingredients

lanolin, mineral oil, purified water, white petrolatum

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150

Made in Korea

image description

MAJOR HYPERTONICITY OPHTHALMIC
sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6489
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	50 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6489-38	1 in 1 CARTON	09/14/2015	10/31/2020
1		3.5 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	09/14/2015	10/31/2020

Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2018

Document Id: 726753d1-021f-f96b-e053-2a91aa0a2288

Set id: 2c1b0be8-afa2-4886-bb91-d82ff90dc997

Version: 2

Effective Time: 20180801

Major Pharmaceuticals