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Name:Visine Maximum Redness Relief Formula
Manufacturer:Johnson & Johnson Healthcare Products, Division Of Mcneil-ppc, Inc
Category:Over-the-counter (OTC) Marketed Drugs


VISINE® Sterile Maximum Redness Relief Formula Lubricant / Redness Reliever Eye Drops

VISINE  MAXIMUM REDNESS RELIEF FORMULA - glycerin, hypromellose, polyethylene glycol 400 and tetrahydrozoline hydrochloride liquid 
Johnson & Johnson Healthcare Products, 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
Maximum Redness Relief Formula
Lubricant / Redness Reliever Eye Drops

Drug Facts

Active ingredients........................................................................... Purpose
Glycerin 0.2%................................................................................... Lubricant
Hypromellose 0.36%........................................................................ Lubricant
Polyethylene glycol 400 1%.............................................................. Lubricant
Tetrahydrozoline HCl 0.05%............................................................. Lubricant

Uses

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

Warnings

Ask a doctor before use if you have narrow angle glaucoma.

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • 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-feading, 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 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Other Information

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

Inactive ingredients

Benzalkonium chloride, boric acid, edentate disodium, purified water, sodium chloride, sodium citrate

Questions?

Call 1888-734-7468, weekdays

PRINCIPAL DISPLAY PANEL - 15 mL Carton

NEW

Visine® Sterile

MAXIMUM
REDNESS RELIEF

FORMULA

LUBRICANT / REDNESS
RELIEVER EYE DROPS

ADVANCED HYDROBLEND™
Long Lasting Moisturizers

SOOTHES AND PROTECTS
irritated eyes

GETS THE RED OUT®

1/2 FL OZ (15 mL)

Principal Display Panel - 15 mL Carton

VISINE   MAXIMUM REDNESS RELIEF FORMULA
glycerin, hypromellose, polyethylene glycol 400, and tetrahydrozaline hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-211
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
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride 0.5 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-211-05 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 (42002-211-05)

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, Division of McNEIL-PPC, Inc (831417154)

Revised: 10/2009 Johnson & Johnson Healthcare Products, 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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