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

----------

Active ingredients                                 Purpose

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

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

Uses

•
relieves dryness of the eye
•
prevents further irritation

Warnings

Do not use

•
if solution changes color or becomes cloudy

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

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

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

Directions

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

Other information

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

Inactive ingredients

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

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Made in Korea

Relabeled By: Preferred Pharmaceuticals Inc.

Natural Balance Tears
MAJOR NATURAL BALANCE 
dextran 70, and hypromellose 2910 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7294(NDC:0904-6493)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7294-11 in 1 CARTON01/04/201908/05/2021
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/04/201908/05/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7294)

Revised: 8/2021
Document Id: 4c8f1ce4-8bf7-4e37-8f16-ce2aaaa8f626
Set id: 85bbfe24-8790-4643-a767-9fb4cecfb32c
Version: 3
Effective Time: 20210805
 
Preferred Pharmaceuticals Inc.