TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, and DEXTRAN 70

FDA Drug Profile — Colirio Ocusan

Drug Details

Generic Name
TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, and DEXTRAN 70
Brand Names
Colirio Ocusan
Application Number
M018
Sponsor
DLC Laboratories, Inc.
NDC Codes
1
Dosage Forms
LIQUID
Routes
OPHTHALMIC
Active Ingredients
DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, TETRAHYDROZOLINE HYDROCHLORIDE

Indications and Usage

Use for the relief of redness of the eye due to minor eye irritations 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 breastfeeding, 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.