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NDC 11822-9854-09 Artifical Tears .3; 1 g/100mL; g/100mL Details

Artifical Tears .3; 1 g/100mL; g/100mL

Artifical 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	11822-9854
Product ID	11822-9854_c72c4ddc-72c3-4c82-affc-ae7f66309f15
Associated GPIs	98600065004000 86209902602020
GCN Sequence Number	008482
GCN Sequence Number Description	petrolatum,white JELLY (G) TOPICAL
HIC3	U6E
HIC3 Description	OINTMENT/CREAM BASES
GCN	36369
HICL Sequence Number	003774
HICL Sequence Number Description	PETROLATUM,WHITE
Brand/Generic	Generic
Proprietary Name	Artifical Tears
Proprietary Name Suffix	n/a
Non-Proprietary Name	Glycerin and Propylene Glycol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	.3; 1
Active Ingredient Units	g/100mL; g/100mL
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	2022-12-31

Package

Package Images

NDC 11822-9854-09 (11822985409)

Pricing Information	N/A
NDC Package Code	11822-9854-9
Billing NDC	11822985409
Package	1 BOTTLE, DROPPER in 1 CARTON (11822-9854-9) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2010-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5a435dbc-669f-49c9-abf2-5e35f1e3d578 Details

Active ingredients

Glycerin (0.3%)

Propylene glycol (1.0%)

Purpose

Lubricant

Uses

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

Warnings

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
•: serious side effects associated with use of the product may be reported to the phone number provided below

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?

Call: 1-866-767-8975

U.S. Patent No. 5,800,807

DISTRIBUTED BY: RITE AID

30 HUNTER LANE, CAMP HILL, PA 17011

MADE IN USA

ITEM 398549

3123703

Package/Label Principal Display Panel

RITE

AID®

PHARMACY

eye care

artificial

tears

lubricant eye drops

DRY EYE FORMULA

fast relief from

age-related dry eyes

replenishes tears

refreshes eyes

Sterile

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

ARTIFICAL TEARS

glycerin and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-9854
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.3 g in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	1 g in 100 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:11822-9854-9	1 in 1 CARTON	09/01/2010
1		30 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	09/01/2010

Labeler - Rite Aid Corporation (014578892)

Registrant - Baush & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		114406598	MANUFACTURE(11822-9854)

Revised: 12/2018

Document Id: c72c4ddc-72c3-4c82-affc-ae7f66309f15

Set id: 5a435dbc-669f-49c9-abf2-5e35f1e3d578

Version: 3

Effective Time: 20181203