FREDS DRY EYE RELIEF- glycerin solution

FREDS DRY EYE RELIEF by

Drug Labeling and Warnings

FREDS DRY EYE RELIEF by is a Otc medication manufactured, distributed, or labeled by HANLIM PHARM. CO., LTD., UNITED EXCHANGE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                Purpose

Glycerin 0.2% ....................................................................Lubricant

Polyethylene Glycol 400 1% ...............................................Lubricant

Hypromellose 0.2% ............................................................Lubricant

PURPOSE

Uses

• for the temporary relief of burning and irritation due to dryness of the eye
• for protection against further irritation
  

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

• 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: ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycine, magnesium chloride, potassium chloride, purified water,

sodium borate, sodium chloride, sodium citrate, and sodium lactate

DOSAGE & ADMINISTRATION

Distributed by: Fred's Inc.

                      4300 New Getwell Rd.

                      Memphis, TN 38118

www.fredsinc.com

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

FREDS DRY EYE RELIEF 
glycerin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-1189
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.002 mL  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.01 mL  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	0.002 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
DEXTROSE (UNII: IY9XDZ35W2)
GLYCINE (UNII: TE7660XO1C)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LACTATE (UNII: TU7HW0W0QT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-1189-9	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	12/06/2010

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

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
HANLIM PHARM. CO., LTD.		687986034	manufacture