RITE AID HYDRATION LUBRICANT EYE DROPS- polyethylene glycol 400, propylene glycol solution/ drops
Rite Aid Corporation

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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Rite Aid Hydration Lubricant Eye Drops 10mL(PLD)

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purposes

Lubricant

Use

for use as a protectant against further irritation or to relieve 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 experience any of the following:

eye pain
changes in vision occur
continued redness or irritation of the eye
condition worsens or persists for more than 72 hours

Keep out of reach of children.

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

Directions

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

Other information

Store at temperature, not exceeding 59°F(15°C).

Inactive ingredients

boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium hydroxide

Questions or comments?

Call 1-888-527-4276

Rite Aid Hydration Lubricant Eye Drops 10mL

RITE AID HYDRATION LUBRICANT EYE DROPS
polyethylene glycol 400, propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0203
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A)	POLYETHYLENE GLYCOL 400	0.4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0203-1	1 in 1 BOX	01/06/2023
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	01/06/2023

Labeler - Rite Aid Corporation (014578892)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
Unimed		688016567	manufacture(11822-0203) , pack(11822-0203) , label(11822-0203)

Revised: 1/2023

Document Id: f19facbd-037b-3320-e053-2995a90a3546

Set id: ecac1351-e944-21da-e053-2995a90a6d34

Version: 2

Effective Time: 20230106

Rite Aid Corporation