MAJOR NATURAL BALANCE- dextran 70, and hypromellose 2910 solution/ drops

Major Natural Balance by

Drug Labeling and Warnings

Major Natural Balance by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                 Purpose

Dextran 70 0.1%................................ Lubricant

Hypromellose 2910 0.3%..................... Lubricant

PURPOSE

Uses

• relieves dryness of the eye
• prevents further irritation

WARNINGS

Warnings

Do not use

• if solution changes color or becomes cloudy

WHEN USING

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use
• remove contact lenses before using

ASK DOCTOR

Stop use and ask a doctor

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

INDICATIONS & USAGE

Directions

• instill 1 to 2 drops in the affected eye(s) as needed

STORAGE AND HANDLING

Other information

• store at 15°-25°C (59-77°F)
• keep tightly closed

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, potassium chloride, purified water, sodium borate, sodium chloride

DOSAGE & ADMINISTRATION

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Made in Korea

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAJOR NATURAL BALANCE 
dextran 70, and hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-7294(NDC:0904-6493)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg  in 1 mL
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35)	HYPROMELLOSE 2910 (4000 MPA.S)	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-7294-1	1 in 1 CARTON	01/04/2019
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/04/2019

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-7294)