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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 4, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                 Purpose

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

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

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  • PURPOSE

    Uses

    relieves dryness of the eye
    prevents further irritation
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  • WARNINGS

    Warnings

    Do not use

    if solution changes color or becomes cloudy
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  • 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
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  • 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
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  • 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.

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  • INDICATIONS & USAGE

    Directions

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

    Other information

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

    Inactive ingredients

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

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  • DOSAGE & ADMINISTRATION

    Distributed by:

    Major Pharmaceuticals

    31778 Enterprise Drive

    Livonia, MI 48150 USA

    Made in Korea

    Relabeled By: Preferred Pharmaceuticals Inc.

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  • 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)
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