IMPROVUE LUBRICANT (hypromellose 2208- 15000 mpa.s solution/ drops

ImproVue by

Drug Labeling and Warnings

ImproVue by is a Otc medication manufactured, distributed, or labeled by Oculus Surgical, Inc., OASIS Medical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Hypromellose (1.7%)

Purpose

Ophthalmic Lubricant

Indications

• For the temporary relief of burning and irritation due to dryness of the eye.
• For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings

• For external use only.
• To avoid contamination do not touch tip of container or applicator to any surface.
• Do not reuse. Once opened, discard.

Stop use and ask a doctor if

• If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
• If solution changes color or becomes cloudy, do not use.

Keep out of reach of children

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

Directions

• Remove cap from syringe and screw on applicator tip.
• Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

• Do not use if pouch is damaged or has been previously opened.
• Protect from freezing
• Store at or below 25°C (77°F)

Inactive Ingredients

Calcium chloride dihydrate, hydrochloric acid1, magnesium chloride hexahydrate, potassium chloride, purified water, sodium acetate trihydrate, sodium chloride, sodium citrate dihydrate, and sodium hydroxide1

1 May contain one or more of these ingredients for pH adjustment

Questions or Comments?

(855) 734-2466 or (772) 236-2622 or log onto www.oculussurgical.com

PRINCIPAL DISPLAY PANEL - 6 Pouch Carton

ImproVue®

Ophthalmic Lubricant Drops

• Sterile
• Preservative-free
• Single use, disposable container

Contains:

6 Pouches, each Pouch containing
1 Single Use Syringe, 0.07 fl oz (2 ml)
1 Single Use Applicator Tip

OCULUS®
SURGICAL
www.oculussurgical.com

INGREDIENTS AND APPEARANCE

IMPROVUE   LUBRICANT
hypromellose 2208 (15000 mpa.s) solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62144-5510
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) (HYPROMELLOSE 2208 (15000 MPA.S) - UNII:Z78RG6M2N2)	HYPROMELLOSE 2208 (15000 MPA.S)	17 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Calcium Chloride (UNII: M4I0D6VV5M)
Hydrochloric Acid (UNII: QTT17582CB)
Magnesium Chloride (UNII: 02F3473H9O)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Acetate (UNII: 4550K0SC9B)
Sodium Chloride (UNII: 451W47IQ8X)
Trisodium Citrate Dihydrate (UNII: B22547B95K)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62144-5510-5	6 in 1 CARTON	06/25/2014
1		1 in 1 POUCH
1		2 mL in 1 SYRINGE, PLASTIC; 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	06/25/2014

Labeler - Oculus Surgical, Inc. (015409582)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS Medical, Inc.		194121018	MANUFACTURE(62144-5510)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS Medical, Inc.		024362989	PACK(62144-5510)