Polyethylene glycol 400, Tetrahydrozoline HCl

FDA Drug Profile — Glitch Advanced Relief Eye Drops, Code Red Eye Drops Redness Relief, Foster and Thrive Advanced Relief Eye Drops, Family Wellness Advanced Redness Relief Eye Drops

Drug Details

Generic Name
Polyethylene glycol 400, Tetrahydrozoline HCl
Brand Names
Glitch Advanced Relief Eye Drops, Code Red Eye Drops Redness Relief, Foster and Thrive Advanced Relief Eye Drops, Family Wellness Advanced Redness Relief Eye Drops
Application Number
M018
Sponsor
Misemer Pharmaceutical, Inc
NDC Codes
4
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HYDROCHLORIDE

Indications and Usage

Uses relieves dryness of the eyes for the temporary relief of discomfort and redness of the eye due to minor eye irritations for the temporary relief of burning and irritation due to exposure to wind or sun for protection against further irritation

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 touch tip of container to any surface to avoid contamination replace cap after using do not use if this solution changes color or becomes cloudy 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 (1-800-222-1222) right away.