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NDC 50268-0065-30 carboxymethylcellulose sodium 10 mg/mL Details

carboxymethylcellulose sodium 10 mg/mL

carboxymethylcellulose sodium is a OPHTHALMIC GEL in the HUMAN OTC DRUG category. It is labeled and distributed by AvPAK. The primary component is CARBOXYMETHYLCELLULOSE SODIUM.

Product Information

NDC	50268-0065
Product ID	50268-065_ed84d1cf-ae3d-bbf8-e053-2995a90a7f9e
Associated GPIs	86200010104031
GCN Sequence Number	062795
GCN Sequence Number Description	carboxymethylcellulose sodium DROPER GEL 1 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	98569
HICL Sequence Number	003843
HICL Sequence Number Description	CARBOXYMETHYLCELLULOSE SODIUM
Brand/Generic	Generic
Proprietary Name	carboxymethylcellulose sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	carboxymethylcellulose sodium
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	OPHTHALMIC
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	CARBOXYMETHYLCELLULOSE SODIUM
Labeler Name	AvPAK
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50268-0065-30 (50268006530)

Pricing Information	N/A
NDC Package Code	50268-065-30
Billing NDC	50268006530
Package	30 VIAL, SINGLE-USE in 1 CARTON (50268-065-30) / .4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2020-11-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b4697319-438e-2ec8-e053-2a95a90abb56 Details

Active ingredient

Carboxymethylcellulose sodium 1%

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.
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.
If solution changes color or becomes cloudy, do not use.

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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

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

Use only if single-use container is intact.
Store at room temperature 15°-30°C (59°-86°F).
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Calcium chloride, hydrochloric acid, magnesium chloride, potassium chloride, puried water, sodium chloride, sodium hydroxide and sodium lactate.

Questions or comments?

1-855-361-3993

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CARBOXYMETHYLCELLULOSE SODIUM

carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50268-065
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	10 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50268-065-30	30 in 1 CARTON	11/18/2020
1		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	11/18/2020

Labeler - AvPAK (832926666)

Revised: 11/2022

Document Id: ed84d1cf-ae3d-bbf8-e053-2995a90a7f9e

Set id: b4697319-438e-2ec8-e053-2a95a90abb56

Version: 3

Effective Time: 20221115