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NDC 00904-6329-46 lubricating plus 0.5 g/100mL Details

lubricating plus 0.5 g/100mL

lubricating plus is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM.

Product Information

NDC	00904-6329
Product ID	0904-6329_15de6fee-b0fa-4deb-8265-7bb71ba94c62
Associated GPIs	86200010102021
GCN Sequence Number	030011
GCN Sequence Number Description	carboxymethylcellulose sodium DROPERETTE 0.5 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	37384
HICL Sequence Number	003843
HICL Sequence Number Description	CARBOXYMETHYLCELLULOSE SODIUM
Brand/Generic	Generic
Proprietary Name	lubricating plus
Proprietary Name Suffix	n/a
Non-Proprietary Name	carboxymethylcellulose sodium
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	0.5
Active Ingredient Units	g/100mL
Substance Name	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Labeler Name	Major Pharmaceuticals
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 00904-6329-46 (00904632946)

Pricing Information
NDC Package Code	0904-6329-46
Billing NDC	00904632946
Package	6 POUCH in 1 CARTON (0904-6329-46) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2013-05-09
NDC Exclude Flag	N
Price Per Unit	0.21984
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	LUBRICATING PLUS 0.5% EYE DRPS
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL e1e95b7f-9282-4642-af7e-5d0c11ce6bd9 Details

Active ingredient (in each single-use container)

Carboxymethylcellulose sodium 0.5%

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

Do not use

if solution changes color or becomes cloudy

When using this product

to avoid contamination

•: do not touch tip of container to any surface
•: do not reuse
•: once opened, discard
•: do not touch unit-dose tip to eye

Stop use and ask a doctor if

•: you experience eye pain
•: changes in vision occur
•: redness or irritation of the eye continues
•: redness or irritation of the eye 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 (1-800-222-1222).

Directions

•: to open, twist and pull tab to remove
•: instill 1 or 2 drops in the affected eye(s) as needed and discard container

Other information

•: store at 20-25°C (68-77°F)
•: RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium lactate solution, water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

1-800-616-2471

Package/Label Principal Display Panel

COMPARE TO the active ingredient of REFRESH PLUS®

MAJOR®

Lubricating PLUS

Lubricant Eye Drops

Immediate, soothing relief for dry eyes

Moisturizing Relief

Carboxymethylcellulose Sodium 0.5%

30 Sterile Single-Use Containers

0.01 FL OZ (0.4 mL) each

Actual Size

INGREDIENTS AND APPEARANCE

LUBRICATING PLUS

carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6329
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6329-46	6 in 1 CARTON	05/09/2013
1		5 in 1 POUCH
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC:0904-6329-51	10 in 1 CARTON	05/31/2013
2		5 in 1 POUCH
2		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
3	NDC:0904-6329-58	14 in 1 CARTON	05/31/2013	10/01/2014
3		5 in 1 POUCH
3		0.4 mL in 1 VIAL, SINGLE-USE; 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	05/09/2013

Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2022

Document Id: 15de6fee-b0fa-4deb-8265-7bb71ba94c62

Set id: e1e95b7f-9282-4642-af7e-5d0c11ce6bd9

Version: 5

Effective Time: 20221110