Sunmark Eye Drops Original Formula
Tetrahydrozoline HCl · Solution/ Drops · Ophthalmic
Active ingredient
Active Ingredient Tetrahydrozoline HCL 0.05%
Purpose
Purpose Redness reliever
Uses
Uses relieves redness of the eye due to minor eye irritations
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 to avoid contamination, do not touch tip of container to any surface. Replace cap after using if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding ask a health professional before use Keep out of reach of chlidren If swallowed, get medical help or contact a Poison Control Center right away
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 to avoid contamination, do not touch tip of container to any surface. Replace cap after using if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using
Stop use and ask a doctor
Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
Pregnancy 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 chlidren If swallowed, get medical help or contact a Poison Control Center right away
Directions
Directions Instill 1 or 2 drops in the affected eye(s) up to four times daily
Inactive ingredients
Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride
Label text from the FDA structured product label by Strategic Sourcing Services LLC (revised Dec 23, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Tetrahydrozoline Hydrochloride in 1 product
Sunmark Eye Drops Original Formula NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 49348-037 | Tetrahydrozoline Hydrochloride .05 g/100mL Solution/ Drops | Strategic Sourcing Services LLC | OTC MONOGRAPH DRUG |
Sunmark Eye Drops Original Formula recalls
- D-0897-2023 Jul 19, 2023 · Class II · Ongoing
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. - D-0320-2015 Dec 31, 2014 · Class III · Terminated
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Frequently asked questions
What is Sunmark Eye Drops Original Formula used for?
Uses relieves redness of the eye due to minor eye irritations
Who makes Sunmark Eye Drops Original Formula?
Sunmark Eye Drops Original Formula is listed by 1 labeler in the FDA NDC directory, including Strategic Sourcing Services LLC.
Has Sunmark Eye Drops Original Formula been recalled?
The FDA enforcement database lists 2 recalls for Sunmark Eye Drops Original Formula, most recently D-0897-2023 (class ii): CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.