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Name: Nwi Original Manufacturer: New World Imports, Inc. Category: Over-the-counter (OTC) Marketed Drugs
tetrahydrozoline hydrochloride solution NEW WORLD IMPORTS, INC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient Purpose
Tetrahydrozoline HCL 0.05% ..................................................Redness reliever
for the relief of redness of the eyes due to minor eye irritations
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 the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor
some users may experience a brief tingling sensation
store at 15
o to 25 oC (59 o to 77 oF)
Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate
New World Imports
160 Athens Way
Nashville, TN 37228
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tetrahydrozoline hydrochloride solution
HUMAN OTC DRUG
Item Code (Source)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
0.5 mg in 1 mL
1 BOTTLE ( BOTTLE) in 1 CARTON
contains a BOTTLE
15 mL in 1 BOTTLE
This package is contained within the CARTON (51824-005-50)
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph final
Labeler - NEW WORLD IMPORTS, INC.
Registrant - UNITED EXCHANGE CORP. (840130579)
HANLIM PHARM. CO., LTD.
Revised: 01/2011 NEW WORLD IMPORTS, INC.