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Visine Advanced Relief

Dosage form: kit
Ingredients: Dextran 70 1mg in 1mL, Polyethylene Glycol 400 11.28mg in 1mL, Povidone 10mg in 1mL, Tetrahydrozoline Hydrochloride 0.5mg in 1mL
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-214

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®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 1-888-734-7648

PRINCIPAL DISPLAY PANEL - 8 mL Carton

Sterile
Visine®

ADVANCED
Redness +
Irritation Relief
LUBRICANT / REDNESS
RELIEVER EYE DROPS

Gets the
Red Out® +
moisturizes

Hydrating
moisturizers
soothe,
refresh + cool

0.28 FL OZ (8mL)

VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-214
Packaging
#Item CodePackage Description
1NDC:42002-214-451 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, DROPPER 30 mL
Part 22 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 AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextran 70 (Dextran 70) Dextran 701 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 40011.28 mg  in 1 mL
Povidone (Povidone) Povidone10 mg  in 1 mL
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
11 BOTTLE, DROPPER in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34906/03/2011
Part 2 of 2
VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextran 70 (Dextran 70) Dextran 701 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 40011.28 mg  in 1 mL
Povidone (Povidone) Povidone10 mg  in 1 mL
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
12 CARTON in 1 CARTON
11 BOTTLE, DROPPER in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/03/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/03/2011
VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-215
Packaging
#Item CodePackage Description
1NDC:42002-215-251 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE, DROPPER 60 mL
Part 22 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 AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextran 70 (Dextran 70) Dextran 701 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 40011.28 mg  in 1 mL
Povidone (Povidone) Povidone10 mg  in 1 mL
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
12 CARTON in 1 CARTON
11 BOTTLE, DROPPER in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34906/03/2011
Part 2 of 2
VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextran 70 (Dextran 70) Dextran 701 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 40011.28 mg  in 1 mL
Povidone (Povidone) Povidone10 mg  in 1 mL
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
12 CARTON in 1 CARTON
11 BOTTLE, DROPPER in 1 CARTON
18 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/03/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/03/2011
VISINE ADVANCED RELIEF 
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-202
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextran 70 (Dextran 70) Dextran 701 mg  in 1 mL
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 40011.28 mg  in 1 mL
Povidone (Povidone) Povidone10 mg  in 1 mL
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:42002-202-011 BOTTLE, DROPPER in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
2NDC:42002-202-022 CARTON in 1 PACKAGE, COMBINATION
21 BOTTLE, DROPPER in 1 CARTON
230 mL in 1 BOTTLE, DROPPER
3NDC:42002-202-051 BOTTLE, DROPPER in 1 CARTON
315 mL in 1 BOTTLE, DROPPER
4NDC:42002-202-081 BOTTLE, DROPPER in 1 CARTON
48 mL in 1 BOTTLE, DROPPER
5NDC:42002-202-351 BOTTLE, DROPPER in 1 CARTON
519 mL in 1 BOTTLE, DROPPER
6NDC:42002-202-031 BOTTLE, DROPPER in 1 PACKAGE
630 mL in 1 BOTTLE, DROPPER
7NDC:42002-202-041 BOTTLE in 1 BLISTER PACK
78 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34905/15/2011
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 02/2013
Document Id: 9329b993-93c5-4bbe-9f5f-b2dd956a0e59
Set id: a53d1ba2-f42a-40b0-ba37-998b28b51668
Version: 3
Effective Time: 20130207
 
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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