CAREONE EYE DROPS SEASONAL RELIEF- tetrahydrozoline hcl and zinc sulfate solution/ drops

Careone Eye Drops Seasonal Relief by

Drug Labeling and Warnings

Careone Eye Drops Seasonal Relief by is a Otc medication manufactured, distributed, or labeled by FoodHold U.S.A LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purposes

Tetrahydrozoline HCl 0.05%.......Eye redness reliever

Zinc sulfate 0.25%......................Eye astringent

PURPOSE

Uses

• for temporary relief of discomfort and redness of the eye due to minor eye irritations

WARNINGS

For external use only

ASK DOCTOR

Ask a doctor before use if you have narrow angle glaucoma.

WHEN USING

When using this product

• pupils may become enlarged temporarily
• overuse may cause more eye redness
• remove contact lenses before using
• do not use if this solution changes color or becomes cloudy
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

STOP USE

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or lasts more than 72 hours

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

• to open bottle, push cap down and twist counterclockwise
• put 1 to 2 drops in the affected eye(s) up to 4 times daily
• children under 6 years of age: ask a doctor

STORAGE AND HANDLING

• some users may exprience a brief tingling sensation
• store between 15-25ºC (59-77ºF)

INACTIVE INGREDIENT

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

QUESTIONS

Questions or comments?

Call 1-877-846-9949

DOSAGE & ADMINISTRATION

Distributed by:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREONE EYE DROPS SEASONAL RELIEF 
tetrahydrozoline hcl and zinc sulfate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-653
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	2.5 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-653-15	1 in 1 BOX	10/01/2018
1		15 mL in 1 BOTTLE; 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	09/26/2018

Labeler - FoodHold U.S.A LLC (809183973)