Eye Drops Extra (Medic's Choice)

Eye Drops Extra by

Drug Labeling and Warnings

Eye Drops Extra by is a Otc medication manufactured, distributed, or labeled by KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EYE DROPS EXTRA- tetrahydrozoline hydrochloride, polyethylene glycol 400 solution/ drops 
K.C. Pharmaceuticals, 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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Eye Drops Extra (Medic's Choice)

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Polyethylene glycol 400 - Eye lubricant

Tetrahydrozoline HCl - Redness reliever

If swallowed, get medical help or contact a Poison Control Center right away.

• relieves redness of the eye due to minor eye irritations
• as a lubricant to prevent further irritation or to relieve dryness of the eye

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

pupils may become enlarged temporarily
to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
if solution changes color or becomes cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using

Stop use and ask a doctor if you experience

eye pain
changes in vision
continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

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

Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at 15o - 30oC (59o - 86oF)

ask a health professional before use.

EYE DROPS EXTRA 
tetrahydrozoline hydrochloride, polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55651-012
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55651-012-01	1 in 1 CARTON	12/09/2003	12/09/2003
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/09/2003	12/09/2003

Labeler - K.C. Pharmaceuticals, Inc (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(55651-012) , pack(55651-012) , label(55651-012)

Revised: 11/2019

Document Id: 983bb2cb-4943-a07b-e053-2995a90acdc0

34390-5

Set id: 8c12bbb9-7b04-4bd5-9147-fc83f174bec5

Version: 2

Effective Time: 20191126

 

K.C. Pharmaceuticals, Inc