FREDS ASTRINGENT RDENESS RELIEVER EYE- tetrahydrozoline hydrochloride solution

Freds Astringent Rdeness Reliever Eye by

Drug Labeling and Warnings

Freds Astringent Rdeness Reliever Eye by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                                  Purpose

Tetrahydrozoline HCl 0.05%......................................................Redness Reliever

Zinc Sulfate 0.25%..............................................................................Astringent

PURPOSE

Uses

• For temporary relief of discomfort and redness of the eye due to minor eye irritations
  

WARNINGS

Warnings for external use only

ASK DOCTOR

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 tips 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 they 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• Instill 1 or 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 between 15°-25°C (59°-77°F)
  

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride, boric acid, disodium edetate hydrate, purified water, sodium chloride, sodium citrate

DOSAGE & ADMINISTRATION

Distributed By:

Fred's Inc.

4300 New Getwell Rd.

Memphis, TN 38118

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FREDS ASTRINGENT RDENESS RELIEVER EYE 
tetrahydrozoline hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-124
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 mg  in 1 mg
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	0.25 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-124-15	1 in 1 CARTON
1		15 mg in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/30/2013

Labeler - Freds Inc (005866116)