OPTICAL ORIGINAL EYE DROPS  - tetrahydrozoline hydrochloride solution 
TELEVISA CONSUMER PRODUCTS USA

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

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 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

Televisa Consumer Products USA, LLC

4550 Post Oak Place Suite 326

Houston, TX 77027

Made in Korea

image of carton label

OPTICAL ORIGINAL EYE DROPS  
tetrahydrozoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55038-023
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)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55038-023-151 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/31/2012
Labeler - TELEVISA CONSUMER PRODUCTS USA (840246230)

Revised: 10/2012
Document Id: 5c818ba9-0c7a-45c4-8891-d3f4f565f6f6
Set id: dbe4a0b2-358a-40ad-847e-656d05cceab6
Version: 2
Effective Time: 20121031
 
TELEVISA CONSUMER PRODUCTS USA