FREDS ORIGINAL EYE DROPS- tetrahydrozoline hydrochloride solution

FREDS ORIGINAL EYE DROPS by

Drug Labeling and Warnings

FREDS ORIGINAL EYE DROPS by is a Otc medication manufactured, distributed, or labeled by HANLIM PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                          Purpose

Tetrahydrozoline HCL 0.05%........................................Redness Reliever

PURPOSE

Uses

• for the relief of redness of the eyes due to minor eye irritations
  

WARNINGS

Warnings

Ask a doctor before use if you have narrow angle glaucoma

WHEN USING

When using this product

• pupils may become enlarged temporarily
• overuse may cause more eye redness
• remove contact lenses before using
• do not use if this solution changes color or becomes cloudy
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use
  

STOP USE

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or lasts more than 72 hours
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

INDICATIONS & USAGE

Directions

• put 1 to 2 drops in the affected eye(s) up to 4 times daily
• children under 6 years of age: ask a doctor
  

STORAGE AND HANDLING

Other information

• some users may experience a brief tingling sensation
• store at 15o to 25oC (59o to 77oF)
  

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

FREDS ORIGINAL EYE DROPS 
tetrahydrozoline hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-1187
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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-1187-8	1 in 1 CARTON
1		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/14/2010

Labeler - HANLIM PHARM. CO., LTD. (687986034)