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NDC 49035-0454-30 Artifical Tears 3; 10 mg/mL; mg/mL Details

Artifical Tears 3; 10 mg/mL; mg/mL

Artifical Tears is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is GLYCERIN; PROPYLENE GLYCOL.

Product Information

NDC	49035-0454
Product ID	49035-454_c6a0c85b-af66-4c33-9a86-2d84850398a1
Associated GPIs	86209902602020
GCN Sequence Number	051264
GCN Sequence Number Description	glycerin/propylene glycol DROPS 0.3%-1% OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	18449
HICL Sequence Number	002180
HICL Sequence Number Description	GLYCERIN/PROPYLENE GLYCOL
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; 10
Active Ingredient Units	mg/mL; mg/mL
Substance Name	GLYCERIN; PROPYLENE GLYCOL
Labeler Name	Wal-Mart Stores Inc
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 49035-0454-30 (49035045430)

Pricing Information	N/A
NDC Package Code	49035-454-30
Billing NDC	49035045430
Package	1 BOTTLE in 1 CARTON (49035-454-30) / 30 mL in 1 BOTTLE
Marketing Start Date	2017-05-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 99cfea82-afb8-4c5f-ac0c-492204a42c08 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 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:1-888-287-1915

Package/Label Principal Display Panel

NDC 49035-454-30

equate™

Compare to Bausch + Lomb Advanced Eye Relief Dry Eye*

Dry Eye

Relief

Lubricant Eye Drops

Soothing Relief

Glycerin 0.3%

Lubricant

Propylene glycol 1.0%

Lubricant

•: For dryness and irritation
•: 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:49035-454
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:49035-454-15	1 in 1 CARTON	09/01/2010
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49035-454-30	1 in 1 CARTON	05/31/2017
2		30 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	09/01/2010

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Baush & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		114406598	MANUFACTURE(49035-454)

Revised: 4/2021

Document Id: c6a0c85b-af66-4c33-9a86-2d84850398a1

Set id: 99cfea82-afb8-4c5f-ac0c-492204a42c08

Version: 6

Effective Time: 20210401