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Name:Visine Tired Eye Relief Lubricant
Manufacturer:Johnson & Johnson Healthcare Products Inc., Division Of Mcneil-ppc, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


VISINE ® STERILE Tired Eye Relief Lubricant Eye Drops

VISINE  TIRED EYE RELIEF LUBRICANT - glycerin, hypromellose and polyethylene glycol 400 liquid 
Johnson & Johnson Healthcare Products Inc., Division of McNEIL-PPC, Inc.

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.

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VISINE ® STERILE
Tired Eye Relief
Lubricant Eye Drops

Drug Facts

Active ingredients............................................................................. Purpose
Glycerin 0.2%..................................................................................... Lubricant
Hypromellose 0.36%........................................................................... Lubricant
Polyethylene glycol 400 1%................................................................. Lubricant

Uses

  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
  • for protection against further irritation

Warnings

When using this product

  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • put 1 or 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor

Other Information

  • store at 15°C to 25°C (59° to 77°F)

Inactive ingredients

ascorbic acid, benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate, and sodium phosphate dibasic

Questions?

Call 1-800-734-3648, weekdays

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Visine® Sterile

TIRED EYE RELIEF
LUBRICANT EYE DROPS

RELIEF OF
burning, irritated, dry eyes

SOOTHES AND REVIVES
tired, overworked eyes

ADVANCED HYDROBLEND™
Long Lasting Moisturizers

1/2 FL OZ (15 mL)

Principal Display Panel - 15 mL Carton

VISINE   TIRED EYE RELIEF LUBRICANT
glycerin, hyporomellose, and polyethylene glycol 400 liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-212
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Glycerin (Glycerin) Glycerin 2.5 mg  in 1 mL
Hypromellose (Hypromellose) Hypromellose 3.6 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 11 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-212-15 1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 15 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (42002-212-15)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part349 11/15/2009

Labeler - Johnson & Johnson Healthcare Products Inc., Division of McNEIL-PPC, Inc. (831417154)

Revised: 10/2009 Johnson & Johnson Healthcare Products Inc., Division of McNEIL-PPC, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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