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NDC 70000-0089-01 Dry Eye Relief 10 mg/mL Details

Dry Eye Relief 10 mg/mL

Dry Eye Relief is a OPHTHALMIC GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is CARBOXYMETHYLCELLULOSE SODIUM.

Product Information

NDC	70000-0089
Product ID	70000-0089_c607e857-ab5c-cf66-e053-2a95a90aee36
Associated GPIs	86200010104030
GCN Sequence Number	008640
GCN Sequence Number Description	carboxymethylcellulose sodium DRP LQ GEL 1 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	37380
HICL Sequence Number	003843
HICL Sequence Number Description	CARBOXYMETHYLCELLULOSE SODIUM
Brand/Generic	Generic
Proprietary Name	Dry Eye Relief
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	Cardinal Health, 110 dba LEADER
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70000-0089-01 (70000008901)

Pricing Information	N/A
NDC Package Code	70000-0089-1
Billing NDC	70000008901
Package	1 BOTTLE, DROPPER in 1 CARTON (70000-0089-1) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bd262028-32e9-052d-e053-2a95a90a5303 Details

SPL UNCLASSIFIED SECTION

Drug Facts

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.
for used as a protectant against further irritation or to relieve dryness of the eye.

Warnings

For external use only.
To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
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

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
Use before expiration date marked on container.
Discard 90 days after opening.
Store at 59°-86°F (15°-30°C).
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; stabilized oxychloro complex; sodium borate; and sodium chloride, May Contain Hydrochloric Acid and /or Sodium hydroxide to adjust PH.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRY EYE RELIEF

carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0089
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
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CHLORITE (UNII: G538EBV4VF)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0089-1	1 in 1 CARTON	03/09/2021
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	03/09/2021

Labeler - Cardinal Health, 110 dba LEADER (063997360)

Revised: 6/2021

Document Id: c607e857-ab5c-cf66-e053-2a95a90aee36

Set id: bd262028-32e9-052d-e053-2a95a90a5303

Version: 2

Effective Time: 20210630