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


Visine®Advanced Relief

VISINE ADVANCED RELIEF - dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride   
VISINE ADVANCED RELIEF - dextran 70, polyethylene glycol 400, povidone 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®Advanced Relief

Drug Facts

Active ingredients Purpose
Dextran 70 0.1% Lubricant
Polyethylene glycol 400 1% Lubricant
Povidone 1% Lubricant
Tetrahydrozoline HCl 0.05% Redness reliever

Uses

  • for the relief of redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye

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, and sodium chloride

Questions?

call 1-800-223-0182, weekdays

PRINCIPAL DISPLAY PANEL - 30 mL Carton

REDNESS &
IRRITATION
RELIEF

Sterile
Visine®
ADVANCED RELIEF
LUBRIDANT
REDNESS RELIEVER EYE DROPS

  • Gets The Red Out®
    And Moisturizes
  • Unique 3-Moisturizer
    Formula
    Soothes • Refreshes • Cools

1 FL OZ (30 mL)

Principal Display Panel - 30 mL Carton

PRINCIPAL DISPLAY PANEL - 30 mL Carton

REDNESS &
IRRITATION
RELIEF

Sterile
Visine®
ADVANCED RELIEF
LUBRIDANT
REDNESS RELIEVER EYE DROPS

  • Gets The Red Out®
    And Moisturizes
  • Unique 3-Moisturizer
    Formula
    Soothes • Refreshes • Cools

1 FL OZ (30 mL)

Principal Display Panel - 30 mL Carton

VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-214
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-214-45 1 KIT ( KIT) in 1 PACKAGE, COMBINATION None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, DROPPER   30 mL
Part 2 2 BOTTLE, DROPPER   30 mL
Part 1 of 2
VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextran 70 (Dextran 70) Dextran 70 1 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 11.28 mg  in 1 mL
Povidone (Povidone) Povidone 10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride  
Boric Acid  
Edetate Disodium  
Water  
Sodium Borate  
Sodium Chloride  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part349 06/03/2011

Part 2 of 2
VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextran 70 (Dextran 70) Dextran 70 1 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 11.28 mg  in 1 mL
Povidone (Povidone) Povidone 10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride  
Boric Acid  
Edetate Disodium  
Water  
Sodium Borate  
Sodium Chloride  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 2 CARTON ( CARTON) in 1 CARTON contains a CARTON
1 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON This package is contained within the CARTON and contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within a CARTON and a CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 06/03/2011


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 06/03/2011

VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-215
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-215-25 1 KIT ( KIT) in 1 PACKAGE, COMBINATION None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 2 BOTTLE, DROPPER   60 mL
Part 2 2 BOTTLE, DROPPER   16 mL
Part 1 of 2
VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextran 70 (Dextran 70) Dextran 70 1 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 11.28 mg  in 1 mL
Povidone (Povidone) Povidone 10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride  
Boric Acid  
Edetate Disodium  
Water  
Sodium Borate  
Sodium Chloride  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 2 CARTON ( CARTON) in 1 CARTON contains a CARTON
1 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON This package is contained within the CARTON and contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within a CARTON and a CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part349 06/03/2011

Part 2 of 2
VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextran 70 (Dextran 70) Dextran 70 1 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 11.28 mg  in 1 mL
Povidone (Povidone) Povidone 10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride  
Boric Acid  
Edetate Disodium  
Water  
Sodium Borate  
Sodium Chloride  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 2 CARTON ( CARTON) in 1 CARTON contains a CARTON
1 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON This package is contained within the CARTON and contains a BOTTLE, DROPPER
1 8 mL in 1 BOTTLE, DROPPER This package is contained within a CARTON and a CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 06/03/2011


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 06/03/2011

VISINE ADVANCED RELIEF 
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-202
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextran 70 (Dextran 70) Dextran 70 1 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 11.28 mg  in 1 mL
Povidone (Povidone) Povidone 10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium chloride  
boric Acid  
Edetate Disodium  
Water  
Sodium borate  
Sodium Chloride  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-202-01 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (42002-202-01)
2 NDC:42002-202-02 2 CARTON ( CARTON) in 1 PACKAGE, COMBINATION contains a CARTON
2 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON This package is contained within the PACKAGE, COMBINATION (42002-202-02) and contains a BOTTLE, DROPPER
2 30 mL in 1 BOTTLE, DROPPER This package is contained within a CARTON and a PACKAGE, COMBINATION (42002-202-02)
3 NDC:42002-202-05 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
3 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (42002-202-05)
4 NDC:42002-202-08 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
4 8 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (42002-202-08)
5 NDC:42002-202-35 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
5 19 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (42002-202-35)
6 NDC:42002-202-03 1 BOTTLE, DROPPER ( BOTTLE) in 1 PACKAGE contains a BOTTLE, DROPPER
6 30 mL in 1 BOTTLE, DROPPER This package is contained within the PACKAGE (42002-202-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part349 05/15/2011

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

Revised: 05/2011 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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