EXCHANGE SELECT ARTIFICIAL TEARS LUBRICANT EYE DROPS- glycerin, hypromellose, polyethylene glycol 400 solution

Exchange Select Artificial Tears Lubricant Eye Drops by

Drug Labeling and Warnings

Exchange Select Artificial Tears Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Army and Air Force Exchange Service, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

PURPOSE

Purpose

Glycerin....Lubricant

Hypromellose....Lubricant

Polyethylene glycol 400....Lubricant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

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

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using. Keep container tightly closed.
• remove contact lens bvefore using

Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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

DOSAGE & ADMINISTRATION

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

• RETAIN THIS CARTON FOR FUTURE REFERENCE
• Store at 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

Inactive ingredients

dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXCHANGE SELECT ARTIFICIAL TEARS LUBRICANT EYE DROPS 
glycerin, hypromellose, polyethylene glycol 400 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-178
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	0.2 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.2 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-178-01	1 in 1 CARTON	02/12/2020
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	02/12/2020

Labeler - Army and Air Force Exchange Service (001695568)

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

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(55301-178) , pack(55301-178) , label(55301-178)