OPTICLEAR- tetrahydrozoline hcl solution/ drops
Major Pharmaceuticals

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 Drug Facts

Active ingredient

Tetrahydrozoline HCl 0.05%

Purpose

Redness Reliever

Uses

•: relieves redness of the eye due to minor eye irritations

Warnings

Do not use if solution changes color or becomes cloudy

Ask a doctor before use if you have
narrow angle glaucoma

When using this product

•: do not touch tip of container to any surface to avoid contamination
•: overuse may produce increased redness of the eye
•: pupils may become enlarged temporarily

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

•: instill 1 to 2 drops in the affected eye(s) up to four times daily or as directed by a doctor

Other information

•: store at 15° - 30°C (59° - 86°F)
•: keep tightly closed
•: replace cap after use

Inactive ingredients

boric acid, edetate disodium, sodium borate, sodium chloride, purified water.

Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions or comments?

Serious side effects associated with use of this product may be reported to 1800-323-0000

Package/Label Principal Display Panel

NDC 0904-2992-35

MAJOR®

STERILE

OPTI-CLEAR

Tetrahydrozoline Hydrochloride Ophthalmic Solution, USP

Redness Reliever Eye Drops

For minor eye irritations

1/2 fl oz (15 mL)

Compared to active ingredient of Visine®* Original

OPTICLEAR
tetrahydrozoline hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-2992
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
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-2992-35	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2011	03/30/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	10/07/2011	03/30/2014

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		807927397	MANUFACTURE(0904-2992)

Revised: 8/2018

Document Id: 2473a831-0074-45a9-b79d-a4597bb21476

Set id: 03f51762-e9ed-4020-a9d0-9938987fa656

Version: 2

Effective Time: 20180803

Major Pharmaceuticals