CVS LUBRICANT EYE DROPS ULTRA- polyethylene glycol 400, propylene glycol solution

CVS Lubricant Eye Drops Ultra by

Drug Labeling and Warnings

CVS Lubricant Eye Drops Ultra by is a Otc medication manufactured, distributed, or labeled by CVS, K.C. Pharmaceutical, Inc., KC Pharmaceuticals, Inc., Unimed Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Polyethylene glycol 400.........0.4%

Propylene glycol ...................0.3%

PURPOSE

Purposes

Polyethylene glycol 400......Lubricant

Propylene glycol.................Lubricant

INDICATIONS & USAGE

Use

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

WARNINGS

Warnings

For external use only

Do not use

• if this solution changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• 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(s) gets worse or lasts more than 72 hours

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

Other information

• store at 15º-25º C (59º-77º F)
• use only if single-use container is intact
• use before expiration date marked on container
• RETAIN THIS CARTON FOR FUTURE REFERENCE

INACTIVE INGREDIENT

Inactive ingredients

boric acid, hydrochloric acid**, hypromellose, potassium chloride, purified water, sodium chloride, sodium hydroxide**

** May contain these ingredients to adjust pH.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS LUBRICANT EYE DROPS ULTRA 
polyethylene glycol 400, propylene glycol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-752
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-752-01	30 in 1 CARTON	02/12/2021
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 69842-752-02	60 in 1 CARTON	02/12/2021
2		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	02/12/2021

Labeler - CVS (062312574)

Registrant - K.C. Pharmaceutical, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	pack(69842-752) , label(69842-752)

Establishment
Name	Address	ID/FEI	Business Operations
Unimed Pharmaceuticals, Inc.		689852052	manufacture(69842-752) , pack(69842-752) , label(69842-752)