TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400

FDA Drug Profile — Value Health by Prodose Eye Drops, Visine Red Eye Hydrating Comfort Eye Drops

Drug Details

Generic Name
TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400
Brand Names
Value Health by Prodose Eye Drops, Visine Red Eye Hydrating Comfort Eye Drops
Application Number
M018
Sponsor
Prodose, Inc.
NDC Codes
4
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HYDROCHLORIDE

Indications and Usage

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

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.