WALGREENS EYE DROPS ADVANCED RELIEF 15ML- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hci liquid

Walgreens Eye Drops Advanced Relief 15mL by

Drug Labeling and Warnings

Walgreens Eye Drops Advanced Relief 15mL by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Purposes

Lubricant

Lubricant

Lubricant

Redness reliever

Uses

relieves redness of the eye due to minor eye irritations

as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

When using this product

pupils may become enlarged temporarily

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.

if solution changes color or becomes cloudy, do not use

overuse may produce increased redness of the eye

remove contact lens before using

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

instill 1 or 2 drops in the affected eye(s) up to 4 times daily

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Walgreens Eye Drops Advanced Relief 15mL

INGREDIENTS AND APPEARANCE

WALGREENS EYE DROPS ADVANCED RELIEF 15ML 
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hci liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-4547
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.1 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)	POVIDONE	1 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-4547-01	1 in 1 BOX	10/11/2019
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	10/11/2019

Labeler - Walgreen Company (008965063)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(0363-4547) , pack(0363-4547) , label(0363-4547)