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NDC 42126-5200-00 VISCO SHIELD 17 mg/mL Details

VISCO SHIELD 17 mg/mL

VISCO SHIELD is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by OASIS Medical, Inc.. The primary component is HYPROMELLOSE 2208 (15000 MPA.S).

Product Information

NDC	42126-5200
Product ID	42126-5200_b0439dd7-d670-4783-b794-721a157b9c44
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	VISCO SHIELD
Proprietary Name Suffix	Lubricant
Non-Proprietary Name	HYPROMELLOSE 2208 (15000 MPA.S)
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	17
Active Ingredient Units	mg/mL
Substance Name	HYPROMELLOSE 2208 (15000 MPA.S)
Labeler Name	OASIS Medical, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42126-5200-00 (42126520000)

Pricing Information	N/A
NDC Package Code	42126-5200-0
Billing NDC	42126520000
Package	6 POUCH in 1 CARTON (42126-5200-0) / 1 SYRINGE, PLASTIC in 1 POUCH / 2 mL in 1 SYRINGE, PLASTIC
Marketing Start Date	2014-06-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 72d22610-d8ab-4f24-b304-8b013430a7d7 Details

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®

Certain manufacturing operations have been performed by other firms

Principal Display Panel - 2 ml Syringe Carton

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)

Revised: 2/2018

Document Id: b0439dd7-d670-4783-b794-721a157b9c44

Set id: 72d22610-d8ab-4f24-b304-8b013430a7d7

Version: 4

Effective Time: 20180202