VISCO SHIELD Lubricant

Dosage form: solution/ drops
Ingredients: HYPROMELLOSE 2208 (15000 MPA.S) 17mg in 1mL
Labeler: OASIS Medical, Inc.
NDC Code: 42126-5200

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

VISCO SHIELD® Topical Drops

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 acid, magnesium chloride hexahydrate, potassium chloride, purified water, sodium acetate trihydrate, sodium chloride, sodium citrate dihydrate, and sodium hydroxide1


May contain one or more of these ingredients for pH adjustment

Questions or Comments?

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

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

VISCO SHIELD   LUBRICANT
hypromellose 2208 (15000 mpa.s) solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42126-5200
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE 2208 (15000 MPA.S) (HYPROMELLOSE 2208 (15000 MPA.S)) HYPROMELLOSE 2208 (15000 MPA.S)17 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CALCIUM CHLORIDE 
MAGNESIUM CHLORIDE 
HYDROCHLORIC ACID 
POTASSIUM CHLORIDE 
SODIUM ACETATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:42126-5200-06 POUCH in 1 CARTON
11 SYRINGE, PLASTIC in 1 POUCH
12 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34906/16/2014
Labeler - OASIS Medical, Inc. (194121018)
Establishment
NameAddressID/FEIOperations
OASIS Medical, Inc.194121018MANUFACTURE(42126-5200)

Revised: 05/2014
 
OASIS Medical, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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