CAREALL EYEDROPS ORIGINAL- tetrahydrozoline hci solution/ drops

CAREALL Eyedrops Original by

Drug Labeling and Warnings

CAREALL Eyedrops Original by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Tetrahydrozoline HCl 0.05%.........................................................Redness reliever

PURPOSE

Uses

• for the relief of redness of the eyes due to minor eye irritations

WARNINGS

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 the 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 eyes last
• condition worsens or lasts more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

INDICATIONS & USAGE

Directions

• 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

Other information

• Some users may experience a brief tingling sensation
• store at 15° to 25°C (59° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients:

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

DOSAGE & ADMINISTRATION

Distributed by: NWI, Inc. 160 Athens Way. Nashville, TN 37228

(615)329-1906

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL EYEDROPS ORIGINAL 
tetrahydrozoline hci solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-039
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 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-039-05	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/01/2014

Labeler - New World Imports, Inc (075372276)