CAREALL ARTIFICAL TEARS- glycerin, hypromellose, polyethylene glycol 400 solution/ drops

CAREALL Artifical Tears by

Drug Labeling and Warnings

CAREALL Artifical Tears 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

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

PURPOSE

Lubricant

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

For the temporary relief of burning and irritation due to dryness of the eye.  For protection against further irritation.

WARNINGS

When using this product

• 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 and ask a doctor if

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

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

DOSAGE & ADMINISTRATION

Put 1 to 2 drops in the affected eye(s) up to 4 times daily.  Children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Some users may experience a brief tingling sensation

INACTIVE INGREDIENT

benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

QUESTIONS

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

(615)329-1906

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ARTIFICAL TEARS 
glycerin, hypromellose, polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-038
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	2 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
DEXTROSE (UNII: IY9XDZ35W2)
GLYCINE (UNII: TE7660XO1C)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LACTATE (UNII: TU7HW0W0QT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-038-05	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2014

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

Labeler - New World Imports, Inc (075372276)