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NDC 63981-0002-05 moisture eyes lubricant eye drops 20 mg/mL Details

moisture eyes lubricant eye drops 20 mg/mL

moisture eyes lubricant eye drops is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Costco Wholesale Company. The primary component is POVIDONE, UNSPECIFIED.

Product Information

NDC	63981-0002
Product ID	63981-002_1af3d2c2-fdb2-45a2-a0ee-d56bd5f5fe8b
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	moisture eyes lubricant eye drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	moisture eyes lubricant eye drops
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	POVIDONE, UNSPECIFIED
Labeler Name	Costco Wholesale Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63981-0002-05 (63981000205)

Pricing Information	N/A
NDC Package Code	63981-002-05
Billing NDC	63981000205
Package	5 BOTTLE, DROPPER in 1 CARTON (63981-002-05) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-06-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d2d6d830-bc0e-4838-bde9-90250f27e651 Details

Active ingredient

Povidone (2.0%)

Purpose

Lubricant

Uses

■ relieves 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 using

Stop use and ask a doctor if you experience

■ eye pain

■ change in vision

■ continued redness or irritation of the eye

■ or if condition worsens or lasts more than 72 hours

If pregnant or breastfeeding, ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Instill 1 or 2 drop(s) in the affected eye(s) as needed or as directed by your doctor

Other information

■ Storage: 15°-25°C (59°-77°F)

■ Use before expiration date marked on the carton or bottle

Inactive ingredients

benzalkonium chloride (0.005%), boric acid, edetate disodium dihydrate, purified water, sodium borate, sodium chloride, tyloxapol. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Questions?

[phone icon] Call:1-800-774-2678

Package/Label Principal Display Panel

KIRKLAND

Signature

moisture

eyes

LUBRICANT EYE DROPS

LONG LASTING

■ Dry Eye Therapy

■ Comforts

■ Moisturizes

Sterile 0.5 FL OZ EA (15 mL EA) 5 BOTTLES

INGREDIENTS AND APPEARANCE

MOISTURE EYES LUBRICANT EYE DROPS

moisture eyes lubricant eye drops solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63981-002
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TYLOXAPOL (UNII: Y27PUL9H56)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63981-002-05	5 in 1 CARTON	06/26/2020
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	06/26/2020

Labeler - Costco Wholesale Company (103391843)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(63981-002)

Revised: 9/2020

Document Id: 1af3d2c2-fdb2-45a2-a0ee-d56bd5f5fe8b

Set id: d2d6d830-bc0e-4838-bde9-90250f27e651

Version: 3

Effective Time: 20200904