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NDC 11822-4811-03 RITE AID Lubricant Drops 0.06 mg/mL Details

RITE AID Lubricant Drops 0.06 mg/mL

RITE AID Lubricant Drops is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by RITE AID. The primary component is PROPYLENE GLYCOL.

Product Information

NDC	11822-4811
Product ID	11822-4811_dbdc14e9-4df1-5662-e053-2995a90a033f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	RITE AID Lubricant Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	propylene glycol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	0.06
Active Ingredient Units	mg/mL
Substance Name	PROPYLENE GLYCOL
Labeler Name	RITE AID
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 11822-4811-03 (11822481103)

Pricing Information	N/A
NDC Package Code	11822-4811-3
Billing NDC	11822481103
Package	2 BOTTLE, DROPPER in 1 CARTON (11822-4811-3) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2022-04-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dbdc2948-34cc-0301-e053-2995a90abc39 Details

SPL UNCLASSIFIED SECTION

Active Ingredients	Purpose
Propylene Glycol 0.6%	Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye
for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
for use as a protectant against further irritation or to relieve dryness of the eye
for use as a lubricant to prevent 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
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 right away.

Directions

shake well before using
put 1 or 2 drops in the affected eye(s) as needed
see side of carton for directions for use

Other Information

store at room temperature
retain carton for future reference

Inactive Ingredients

benzalkonium chloride solution, boric acid, calcium chloride, magnesium chloride, potassium chloride, castor oil, disodium edetate, polyoxyl 40 hydrogenated castor oil, sodium borate, sodium hyaluronate, purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID LUBRICANT DROPS

propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-4811
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.06 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CASTOR OIL (UNII: D5340Y2I9G)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BORATE (UNII: 91MBZ8H3QO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-4811-3	2 in 1 CARTON	04/04/2022
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	04/04/2022

Labeler - RITE AID (014578892)

Revised: 4/2022

Document Id: dbdc14e9-4df1-5662-e053-2995a90a033f

Set id: dbdc2948-34cc-0301-e053-2995a90abc39

Version: 2

Effective Time: 20220404