ARTIFICIAL TEARS- glycerin, hypromellose, polyethylene glycol 400 liquid

Artificial Tears by

Drug Labeling and Warnings

Artificial Tears by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene Glycol 400 1%

Purpose

Lubricant

Lubricant

Lubricant

Uses

• for use as a protectant against further irritation or to relieve dryness of the eye
• for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
  

Warnings

Do not use this product if

solution changes color or becomes cloudy

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
  

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using. Keep container tightly closed.
• remove contact lens before using
  

Keep out of reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Do not use if the tamper-resistant bottle cap is broken or opened.
• RETAIN THIS CARTON FOR FUTURE REFERENCE
• store between 15° to 30°C (59°F to 86°F)

Inactive ingredients

aminoacetic acid, ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

Package principal display panel

Care One Tears

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
glycerin, hypromellose, polyethylene glycol 400 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-865
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
DEXTROSE (UNII: IY9XDZ35W2)
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)
GLYCINE (UNII: TE7660XO1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-865-05	1 in 1 BOX	09/10/2010
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	09/06/2010

Labeler - American Sales Company (809183973)