Visco Shield Lubricant (Hypromellose 2208 (15000 Mpa.s)) Solution/ Drops [Oasis Medical, Inc.] -

VISCO SHIELD LUBRICANT (HYPROMELLOSE 2208 (15000 MPA.S)) SOLUTION/ DROPS [OASIS MEDICAL, INC.]
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NDC	42126-5200-0
Set ID	72d22610-d8ab-4f24-b304-8b013430a7d7
Category	HUMAN OTC DRUG LABEL
Packager	OASIS Medical, Inc.
Generic Name
Product Class
Product Number
Application Number	PART349

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part349	06/16/2014

Labeler - OASIS Medical, Inc. (194121018)

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

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Medic

Stop use and ask a doctor if