Visine Red Eye Comfort Solution/ Drops
FDA Label NDC 69968-0355

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Visine Red Eye Comfort (NDC 69968-0355). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - ask doctor, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

Active Ingredient

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

Otc - Ask Doctor

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day
  • children under 6 years of age: consult a doctor
  • children under 2 years of age: do not use

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

ascorbic acid, boric acid, dextrose, glycerin, glycine, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, sodium citrate, sodium lactate, sodium phosphate dibasic

Questions?

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

Principal Display Panel - 15 Ml Bottle Carton

VISINE®
RED EYE
COMFORT
REDNESS RELIEVER EYE DROPS

FAST ACTING
Redness Relief

STERILE
1/2 FL OZ (15mL)

Principal Display Panel (15 mL Bottle Carton)

Principal Display Panel (15 mL Bottle Carton)

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