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

VISCO SHIELD by

Drug Labeling and Warnings

VISCO SHIELD by is a Otc medication manufactured, distributed, or labeled by 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

Uses

• 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
• Once opened, discard
• Do not reuse

Stop use and ask a doctor 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.

Questions, or comments

(800) 631-7180 or (909) 305-5400 or log onto www.oasistears.com

Other information

• Do not sue if pouch is damage or has been previously opened
• Protect from freezing
• Store at or below 77°F/25°C

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

PRINCIPAL DISPLAY PANEL - 2 ml Syringe Carton

VISCO SHIELD®
Topical Drops

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

OASIS®

OASIS® Medical, Glendora CA 91741 USA
© 2014 OASIS Medical
P940 3/2014

Certain manufacturing operations have been performed by other firms

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42126-5200
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)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
HYDROCHLORIC ACID (UNII: QTT17582CB)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42126-5200-0	6 in 1 CARTON	06/16/2014
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	06/16/2014

Labeler - OASIS Medical, Inc. (194121018)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS Medical, Inc.		194121018	MANUFACTURE(42126-5200)