ARTIFICIAL TEARS- glycerin solution/ drops

Artificial Tears by

Drug Labeling and Warnings

Artificial Tears by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Purpose

Lubricant

Uses

• for protection against further irritation
• for temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

WHEN USING

When using this product

• to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• remove contact lenses before using

STOP USE

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

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.

Directions

• instill 1 or 2 drops in the affected eye(s) as needed
• children under 6 years of age: ask a doctor

Other information

• store at 15°-30°C (59°-86°F)

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

1-800-540-3765

package label

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-4555(NDC:57896-181)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.002 mg  in 1 mg
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	0.002 mg  in 1 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.01 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-4555-5	15 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/01/2018

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4555)