WALGREENS EYE DROPS ORIGINAL 15ML AND TWIN PACK- tetrahydrozoline hci liquid

Walgreens Eye Drops Original 15mL and twin pack by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Tetrahydrozoline HCl 0.05%

Purpose

Redness reliever

Use

relieves redness of the eye due to minor eye irritations

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, sodium chloride

Walgreens Eye Drops Original 15mL

Walgreens Eye Drops Original 15mL twin pack

INGREDIENTS AND APPEARANCE

WALGREENS EYE DROPS ORIGINAL 15ML AND TWIN PACK 
tetrahydrozoline hci liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-4550
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-4550-01	1 in 1 BOX	10/14/2019
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0363-4550-02	2 in 1 BOX	10/14/2019
2		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	10/14/2019

Labeler - Walgreens Company (008965063)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(0363-4550) , pack(0363-4550) , label(0363-4550)