PREMIER VALUE ORIGINAL- tetrahydrozoline hydrochloride solution 
HANLIM PHARM. CO., LTD.

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

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 chloride, and sodium borate

Distributed By:

Chain Drug Consortium, LLC.

3301 NW Boca Raton Blvd.

Suite 101

Boca Raton, FL 33431

image of carton labelEnter section text here

PREMIER VALUE ORIGINAL 
tetrahydrozoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-0101
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-0101-11 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/19/2014
Labeler - HANLIM PHARM. CO., LTD. (687986034)

Revised: 5/2014
Document Id: 2383b6cc-a845-4599-b785-d35391f88cbf
Set id: b75edf79-0bde-46f4-a1d0-ba1b44eb56c4
Version: 2
Effective Time: 20140519
 
HANLIM PHARM. CO., LTD.