SOUND BODY ORIGINAL EYE- tetrahydrozoline hydrochloride solution/ drops 
United Exchange Corp

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

Stop use and ask a doctor if

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

Other information

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

Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

Made in Korea

image description

SOUND BODY ORIGINAL EYE 
tetrahydrozoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-559
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 10 mg
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-559-151 in 1 CARTON
115 mg in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/19/2014
Labeler - United Exchange Corp (840130579)

Revised: 5/2014
Document Id: 109d51b6-58e3-4dac-bff3-053e305c47c0
Set id: aeb724ca-b3a3-4d0b-994f-7abd4026243c
Version: 2
Effective Time: 20140519
 
United Exchange Corp