Dry Eye Relief (Glycerin, Hypromellose, Polyethylene Glycol) Liquid [Mckesson Corporation] -

DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL) LIQUID [MCKESSON CORPORATION]
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NDC	49348-095-29
Set ID	043ccc34-44ee-416a-88bc-f247774e9075
Category	HUMAN OTC DRUG LABEL
Packager	Strategic Sourcing Services LLC
Generic Name
Product Class
Product Number
Application Number	PART349

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ACTIVE INGREDIENT

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%
PURPOSE

Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant
INDICATIONS & USAGE
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

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
DOSAGE & ADMINISTRATION
Directions
- Instill 1 or 2 drops in the affected eye(s) as needed
- Children under 6 years of age: ask doctor
OTHER SAFETY INFORMATION

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE

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

DRY EYE RELIEF
glycerin, hypromellose, polyethylene glycol liquid

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 final	part349	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)

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Medic

DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL) LIQUID [MCKESSON CORPORATION]

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