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


Visine® Summer Spectrum Relief

VISINE  SUMMER SPECTRUM RELIEF - tetrahydrozoline hydrochloride, polyethylene glycol 400, povidone and dextran 70 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® Summer Spectrum 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, 9 AM – 5 PM EST

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Sterile
Visine
®

SUMMER
Spectrum Relief

LUBRICANT / REDNESS
RELIEVER EYE DROPS

Relieves
eye irritation
caused by
swimming,
sun or wind

Moisturizes
to protect against
further irritation

1/2 FL OZ (15mL)

Principal Display Panel – 15 mL Carton

VISINE   SUMMER SPECTRUM RELIEF
tetrahydrozoline hydrochloride, polyethylene glycol 400, povidone, and dextran 70 liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-213
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tetrahydrozoline Hydrochloride (Tetrahydrozoline) Tetrahydrozoline Hydrochloride 0.5 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
Dextran 70 (Dextran 70) Dextran 70 1 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-213-05 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (42002-213-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part349 01/01/2011

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

Revised: 07/2010 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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