NWI ORIGINAL- 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.

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Drug Facts

Active ingredient Purpose

Tetrahydrozoline HCL 0.05% ..................................................Redness reliever

Uses

for the relief of redness of the eyes due to minor eye irritations

Warnings

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.

Directions

put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor

Other information

some users may experience a brief tingling sensation
store at 15o to 25oC (59o to 77oF)

Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

Distributed by:

New World Imports

160 Athens Way

Nashville, TN 37228

615-329-1906

image of carton label Enter section text here

NWI ORIGINAL
tetrahydrozoline hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51824-005
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51824-005-50	1 in 1 CARTON	01/10/2011	01/01/2018
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	01/10/2011	01/01/2018

Labeler - NEW WORLD IMPORTS, INC. (075372276)

Revised: 8/2017

Document Id: ee855777-cd65-4322-9c07-dc503e78c314

Set id: 8b5d86f6-3708-4302-81bf-cd4495f0c475

Version: 5

Effective Time: 20170810

NEW WORLD IMPORTS, INC.