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NDC 36800-0641-65 TOPCARE EYE DROPS 0.5 g/100mL Details

TOPCARE EYE DROPS 0.5 g/100mL

TOPCARE EYE DROPS is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM.

Product Information

NDC	36800-0641
Product ID	36800-641_50a66a1b-d6a4-47f9-9c18-8fedb22a9779
Associated GPIs	51200005000360
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	TOPCARE EYE DROPS
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	Topco Associates LLC
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 36800-0641-65 (36800064165)

Pricing Information	N/A
NDC Package Code	36800-641-65
Billing NDC	36800064165
Package	6 POUCH in 1 CARTON (36800-641-65) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2019-05-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14f4dc43-9b3c-4780-931e-f9c2852d854e 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 sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare health™

COMPARE TO REFRESH PLUS® LUBRICANT EYE DROPS ACTIVE INGREDIENT

SENSITIVE PRESERVATIVE-FREE

Lubricating Plus

Lubricant

Eye Drops

CARBOXYMETHYLCELLULOSE SODIUM 0.5%

Moisturizing Relief for Dry Eyes

Immediate Relief Plus Protection

Actual Size

30 SINGLE-USE CONTAINERS

0.01 FL OZ (0.4 mL) EACH Sterile

INGREDIENTS AND APPEARANCE

TOPCARE EYE DROPS

carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-641
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
Packaging
1	NDC:36800-641-65	6 in 1 CARTON	05/31/2019
1		5 in 1 POUCH
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	05/31/2019

Labeler - Topco Associates LLC (006935977)

Revised: 11/2022

Document Id: 50a66a1b-d6a4-47f9-9c18-8fedb22a9779

Set id: 14f4dc43-9b3c-4780-931e-f9c2852d854e

Version: 4

Effective Time: 20221101