CAREONE ITCHY RELIEF EYE DROPS 15ML- tetrahydrozoline hci, zinc sulfate liquid

CareOne Itchy Relief Eye Drops 15mL by

Drug Labeling and Warnings

CareOne Itchy Relief Eye Drops 15mL by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC., KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Tetrahydrozoline HCI 0.05%

Zinc sulfate 0.25%

Purposes

Redness reliever

Astringent

Uses

• for temporary relief of discomfort and 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 lenses 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 to 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 chloride, sodium citrate

Careone Itchy Relief Eye Drops 15mL

INGREDIENTS AND APPEARANCE

CAREONE ITCHY RELIEF EYE DROPS 15ML 
tetrahydrozoline hci, zinc sulfate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-011
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	0.25 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-011-01	1 in 1 BOX	10/29/2019
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	10/29/2019

Labeler - Retail Business Services, LLC. (967989935)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(72476-011) , pack(72476-011) , label(72476-011)