VISINE ORIGINAL  REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops 
Johnson & Johnson Consumer 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® 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

For external use only.

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 toll-free 888-734-7648 or 215-273-8755 (collect)

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)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
VISINE ORIGINAL   REDNESS RELIEF
tetrahydrozoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-203
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline - UNII:S9U025Y077) Tetrahydrozoline Hydrochloride0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Boric Acid (UNII: R57ZHV85D4)  
Edetate Disodium (UNII: 7FLD91C86K)  
Water (UNII: 059QF0KO0R)  
Sodium Borate (UNII: 91MBZ8H3QO)  
Sodium Chloride (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-203-021 in 1 CARTON10/01/200909/30/2022
115 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2NDC:42002-203-351 in 1 CARTON10/01/200908/31/2016
219 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34910/01/200909/30/2022
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2020
Document Id: 3a707756-04d2-46e0-a2f6-c1425fecb2aa
Set id: e3c41a58-fc93-4e6c-99be-0529edfb54a4
Version: 9
Effective Time: 20200922
 
Johnson & Johnson Consumer Inc.