PREMIER VALUE EYE DROPS MT- polyvinyl alcohol and povidone solution

PREMIER VALUE EYE DROPS MT by

Drug Labeling and Warnings

PREMIER VALUE EYE DROPS MT by is a Otc medication manufactured, distributed, or labeled by HANLIM PHARM. CO., LTD., UNITED EXCHANGE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                 Purpose

Polyvinyl Alcohol 0.5% ........................................................Lubricant

Povidone 0.6% ...................................................................Lubricant

PURPOSE

Uses

• relieves dryness of the eye(s)
• temporary relieves burning and irritations due to dryness of the eye
• protects against further irritation
  

WARNINGS

For external use only.

DO NOT USE

Do not use: If solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

WHEN USING

When using this product

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

STOP USE

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness of irritation of the eye gets worse or lasts more than 72 hours

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

INDICATIONS & USAGE

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Store at 15o-25oC (59o-77oF).
• Children under 6 years of age: Ask a doctor
  

INACTIVE INGREDIENT

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate,

Sodium Phosphate (Mono- and Dibasic)

DOSAGE & ADMINISTRATION

Distributed By:

Chain Drug Consortium, LLC.

3301 NW Boca Raton Blvd. Suite 101

Boca Raton, FL33431

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PREMIER VALUE EYE DROPS MT 
polyvinyl alcohol and povidone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-0224
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE (UNII: SE337SVY37)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-0224-2	1 in 1 CARTON
1		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	10/19/2010

Labeler - HANLIM PHARM. CO., LTD. (687986034)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
HANLIM PHARM. CO., LTD.		687986034	manufacture