CVS SINGLE USE LUBRICANT EYE DROPS- polyethylene glycol 400, and propylene glycol solution/ drops

Cvs Single Use Lubricant Eye Drops by

Drug Labeling and Warnings

Cvs Single Use Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Bershtel Enterprises LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients PurposePolyethylene glycol 400 0.4%......................................LubricantPropylene glycrol 0.3%...............................................Lubricant

PURPOSE

UseFor the temporary relief of burning and irritation due to dryness of the eye

WARNINGS

Warnings For external use only.

DO NOT USE

WHEN USING

When using this productdo not touch tip of container to any surface to avoid contaminationdo not reuseonce opened, discard

STOP USE

Stop use and ask a doctor ifyou feel eye painchanges in vision occurredness or irritation of the eye(s) get worse, persists 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.

DOSAGE & ADMINISTRATION

Ophthalmic - Administration to the external eye.

INDICATIONS & USAGE

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

STORAGE AND HANDLING

Other information Store at room temperature. Protect from light.

INACTIVE INGREDIENT

Inactive ingredientsaminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium chloride, sodium hydroxide, sorbitol, water for injection

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS SINGLE USE LUBRICANT EYE DROPS 
polyethylene glycol 400, and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10564-6553
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	4 mg

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10564-6553-0	1 in 1 CARTON; Type 0: Not a Combination Product	01/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/21/2016

Labeler - Bershtel Enterprises LLC (066659129)