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NDC 11822-9706-05 Lubricant Eye 10 mg/mL Details

Lubricant Eye 10 mg/mL

Lubricant Eye is a OPHTHALMIC GEL in the HUMAN OTC DRUG category. It is labeled and distributed by RITE AID. The primary component is CARBOXYMETHYLCELLULOSE SODIUM.

Product Information

NDC	11822-9706
Product ID	11822-9706_e0fb7ea2-0d68-9506-e053-2a95a90a4df2
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	Lubricant Eye
Proprietary Name Suffix	Rite Aid
Non-Proprietary Name	Carboxymethylcellulose sodium
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	OPHTHALMIC
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	CARBOXYMETHYLCELLULOSE SODIUM
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 11822-9706-05 (11822970605)

Pricing Information	N/A
NDC Package Code	11822-9706-5
Billing NDC	11822970605
Package	1 BOTTLE, DROPPER in 1 CARTON (11822-9706-5) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-10-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e0fb7ecd-d8b5-345e-e053-2a95a90ae917 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Carboxymethylcellulose sodium 1%

Purpose

Eye lubricant

Uses

For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
May be used as a protectant against further irritation.

Warnings

For external use only.
To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
If solution changes color or becomes cloudy, do not use.

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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

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

Other information

Use before expiration date marked on container.
Discard 30 days after opening.
Store at 59°-86°F (15°-30°C).
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; stabilized oxychloro complex; and sodium chloride.

May contain hydrochloric acid and/or sodium hydroxide to adjust pH

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUBRICANT EYE RITE AID

carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-9706
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CHLORITE (UNII: G538EBV4VF)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-9706-5	1 in 1 CARTON	10/03/2020
1		15 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	10/03/2020

Labeler - RITE AID (014578892)

Registrant - Velocity Pharma LLC (962198409)

Revised: 6/2022

Document Id: e0fb7ea2-0d68-9506-e053-2a95a90a4df2

Set id: e0fb7ecd-d8b5-345e-e053-2a95a90ae917

Version: 1

Effective Time: 20220608