Sunmark Dry Eye Relief (PLD)

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%

Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

Uses

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

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 before using

Keep out of reach of children

If accidentally swallowed get medical help or contact a Poison Control Center immediately

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

Directions

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

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE

Store at 15 oC-30 oC (59 o-86 oF)

Inactive ingredients

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

CARTON

SUNMARK DRY EYE RELIEF
glycerin, hypromellose, polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-095
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSES	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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49348-095-29	1 in 1 CARTON	05/01/2013
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M018	05/01/2013

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(49348-095) , pack(49348-095) , label(49348-095)