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Visine Original Redness Relief

Dosage form: liquid
Ingredients: Tetrahydrozoline Hydrochloride 0.5mg in 1mL
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-203

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.

Visine® Original Redness Relief
Eye Drops

Drug Facts

Active ingredients

Tetrahydrozoline HCl 0.05%

Purpose

Redness reliever

Use
  • for the relief of redness of the eye due to minor eye irritations

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-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 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, edetate disodium, purified water, sodium borate, sodium chloride

Questions?

call 1-888-734-7648

Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Sterile
Visine®

ORIGINAL
Redness Relief
TETRAHYDROZOLINE HCl
REDNESS RELIEVER EYE DROPS

Gets the
Red Out®

Fast-acting
formula

1/2 FL OZ (15mL)

VISINE ORIGINAL   REDNESS RELIEF
tetrahydrozoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-203
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Boric Acid 
Edetate Disodium 
Water 
Sodium Borate 
Sodium Chloride 
Packaging
#Item CodePackage Description
1NDC:42002-203-021 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
2NDC:42002-203-011 BOTTLE (BOTTLE) in 1 CARTON
230 mL in 1 BOTTLE
3NDC:42002-203-351 BOTTLE (BOTTLE) in 1 CARTON
319 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34908/25/2011
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 05/2012
Document Id: 0e0bd1f6-18e8-464f-92e5-1a2fb49d7458
Set id: e3c41a58-fc93-4e6c-99be-0529edfb54a4
Version: 3
Effective Time: 20120509
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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