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NDC 11822-0011-05 artificial tears 3; 10 mg/mL; mg/mL Details

artificial tears 3; 10 mg/mL; mg/mL

artificial tears is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by RITE AID CORPORATION. The primary component is GLYCERIN; PROPYLENE GLYCOL.

Product Information

NDC	11822-0011
Product ID	11822-0011_6d14ded0-27cb-49e4-b8d1-3860d1211675
Associated GPIs	43200010001210 95576030000320
GCN Sequence Number	022210
GCN Sequence Number Description	guaifenesin LIQUID 100 MG/5ML ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02512
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	artificial tears
Proprietary Name Suffix	n/a
Non-Proprietary Name	lubricant eye drops
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	3; 10
Active Ingredient Units	mg/mL; mg/mL
Substance Name	GLYCERIN; PROPYLENE GLYCOL
Labeler Name	RITE AID CORPORATION
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11822-0011-05 (11822001105)

Pricing Information	N/A
NDC Package Code	11822-0011-5
Billing NDC	11822001105
Package	1 BOTTLE in 1 CARTON (11822-0011-5) / 15 mL in 1 BOTTLE
Marketing Start Date	2017-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fd799b50-68ac-4d9a-8975-d0bfa465a4c3 Details

Active ingredients

Glycerin (0.3%)

Propylene glycol (1.0%)

Purpose

Lubricant

Lubricant

Uses

▪: temporary relief of burning and irritation due to dryness of the eye
▪: prevents further irritation

Warnings

For external use only

Do not use

▪: if solution changes color or becomes cloudy

When using this product

▪: do not touch tip of container to any surface to avoid contamination
▪: remove contact lenses before using
▪: replace cap after use

Stop use and ask a doctor if

▪: you experience 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

▪: instill 1 or 2 drops in the affected eye(s) as needed

Other information

▪: store at 15-25°C (59-77°F)
▪: keep tightly closed
▪: use before expiration date marked on the carton and bottle

Inactive ingredients

benzalkonium chloride (0.01%), boric acid, edetate disodium, potassium chloride, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Questions or comments?

Call: 1-866-767-8975

DISTRIBUTED BY:

RITE AID,

30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Principal Display Panel – 30 mL Carton

ARTIFICIAL

TEARS

lubricant eye drops

soothing relief for

dryness and irritation

STERILE

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS

lubricant eye drops solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0011
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	3 mg in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0011-3	1 in 1 CARTON	01/01/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:11822-0011-5	1 in 1 CARTON	01/01/2017
2		15 mL in 1 BOTTLE; 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	01/01/2017

Labeler - RITE AID CORPORATION (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		114406598	MANUFACTURE(11822-0011)

Revised: 9/2021

Document Id: 6d14ded0-27cb-49e4-b8d1-3860d1211675

Set id: fd799b50-68ac-4d9a-8975-d0bfa465a4c3

Version: 3

Effective Time: 20210923