LUBRICANT EYE- polyethylene glycol 400 and propylene glycol solution/ drops
Rite Aid

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

Lubricant

Uses

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

Warnings

For external use only.

Do not use

If this product 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, persists or lasts more than 72 hours

Keep out of reach of children.

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

Directions

shake well before using
instill 1 or 2 drops in the affected eye(s) as needed

Other information

store at 20° to 25°C (68° to 77°F) [Room Temperature].

Inactive ingredients

2-amino-2-methyl-1-propanol, Benzalkonium Chloride, Boric Acid, Hydrochloric Acid*, Hypromellose USP, Potassium Chloride, Purified Water, Sodium Chloride, Sodium Hydroxide*, Sorbitol solution.

*May contain one or more of these ingredients to adjust pH.

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 11822-2701-1

Rite Aid Logo

lubricant

eye drops

dry eye relief

STERILE 10 mL (0.34 FL OZ)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

TWIN PACK

Rite Aid Logo

*Compare to the active ingredients in

Systane Ultra® Lubricant Eye Drops

NDC 11822-2701-1

lubricant

eye drops

dry eye relief

HIGH PERFORMANCE

extended protection

fast symptom relief

1- 10 mL

STERILE (0.34 FL OZ) BOTTLES

Principal Display Panel Text for Carton Label

LUBRICANT EYE
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-2701
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	4 mg in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Aminomethylpropanol (UNII: LU49E6626Q)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57ZHV85D4)
Hydrochloric Acid (UNII: QTT17582CB)
Hypromelloses (UNII: 3NXW29V3WO)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Sorbitol (UNII: 506T60A25R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-2701-1	2 in 1 CARTON	04/24/2015	01/31/2017
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	04/24/2015	01/31/2017

Labeler - Rite Aid (014578892)

Revised: 10/2020

Document Id: 22098ca7-4013-4884-857b-021f45c80c8e

Set id: aacd7051-8f9c-4be4-98a6-62a314f7b71b

Version: 2

Effective Time: 20201021

Rite Aid