Visine A.C.: Package Insert and Label Information

VISINE A.C.- tetrahydrozoline hydrochloride and zinc sulfate, unspecified form 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.

Drug Facts

Active ingredients Purpose
Tetrahydrozoline HCl 0.05% Redness reliever
Zinc sulfate 0.25% Astringent

Use

  • for temporary relief of discomfort and 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

  • some users may experience a brief tingling sensation
  • store at 15° to 25°C (59° to 77°F)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

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®
A.C.®
ASTRINGENT / REDNESS
RELIEVER EYE DROPS
Ultra Itchy
Eye Relief

Relieves
itching eyes
due to
pollen, dust
and ragweed

1/2 FL OZ (15mL)

PRINCIPAL DISPLAY PANEL -- 15 mL Bottle Carton
(click image for full-size original)
VISINE A.C.
tetrahydrozoline hydrochloride and zinc sulfate solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-201
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
Zinc Sulfate, Unspecified Form (Zinc Cation) Zinc Sulfate, Unspecified Form 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride
Boric Acid
Edetate Disodium
Water
Sodium Chloride
Sodium Citrate, Unspecified Form
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-201-05 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (42002-201-05)
2 NDC:42002-201-35 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 19 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (42002-201-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part349 11/01/2009 08/30/2021
Labeler — Johnson & Johnson Consumer Inc. (002347102)

Revised: 01/2020 Johnson & Johnson Consumer Inc.

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