Active Ingredients
Active ingredients
Polyethylene glycol 400 1%
Tetrahydrozoline HCl 0.05%
Visine Red Eye Hydrating Comfort Solution/ Drops
FDA Label NDC 85237-1969
14 label sections · Submitted to the FDA by Select Consumer Group · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Consumer Group for the product Visine Red Eye Hydrating Comfort (NDC 85237-1969). 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 active ingredients, purpose, uses, warnings, ask a doctor before use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Lubricant
Redness reliever
Uses
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.
Ask A Doctor Before Use
Ask a doctor before use if you havenarrow angle glaucoma.
When Using This Product
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
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
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding,ask a health professional before use.
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
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
Other information
Store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
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
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Package Label.Principal Display Panel
Uses
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.
Ask a doctor before use
Ask a doctor before use if you have narrow angle glaucoma.
When using this product
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
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
If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
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
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
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