Visine Red Eye Hydrating Comfort Solution/ Drops
FDA Label NDC 73097-018

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Savings Distributors Llc for the product Visine Red Eye Hydrating Comfort (NDC 73097-018). 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, otc - active ingredient, otc - purpose, uses, 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

→ Otc - Active Ingredient

→ Otc - Purpose

→ Uses

→ Warnings

→ Otc - Ask Doctor

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 15 Ml Bottle Carton

Other

Drug Facts

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

Made in Belgium @ J&JCI 2020 www.visine.com

Product is repackaged and distributed with permission of manufacturer by Savings Distributors LLC.,

85 Hoffman Lane, Suite L & M, Islandia, NY 11749

Telephone # 1-800-628-9375. Business Hours 10:00 AM - 6:30 PM

Otc - Active Ingredient

Active ingredient . . . . . . . . . Purpose

Polyethylene glycol 400 1% Lubricant

Tetrahydrozoline HCl 0.05% Redness reliever

Otc - Purpose

Purpose

Uses

for the relief of redness of the eye due to minor eye irritations
for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
for use as a protectant against further irritation or to relieve dryness of the eye

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 • replace cap after each use
do not use if this solution changes color or becomes cloudy
do not touch tip of container to any surface to avoid contamination

Stop Use And Ask A Doctor If

you feel eye pain • redness or irritation of the eye lasts
changes in vision occur • 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, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

Questions?

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

Principal Display Panel - 15 Ml Bottle Carton

VISINE _®
RED EYE
HYDRATING
COMFORT
LUBRICANT/REDNESS RELIEVER EYE DROPS

WORKS IN 30 SECONDS
Redness + Irritation Relief

Lubricates &
Refreshes
STERILE
0.28 FL OZ (8 mL)

* Please review the disclaimer below.

Previous Product 73097-017

Next Product 73098-001