TopCare Health Advanced Moisturizing Plus Redness Relief

Manufacturer: Topco Associates LLC | K.C. Pharmaceuticals, Inc.
Effective date: 2023-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:05:11

Label at a glance#

ProductTopCare Health Advanced Moisturizing Plus Redness Relief

Active ingredientPOVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70

Label structure8 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

OTC - PURPOSE SECTION

Purposes

Dextran 70... Lubricant

Polyethylene glycol 400... Lubricant

Povidone... Lubricant

Tetrahydrozoline HCl... Redness reliever

INDICATIONS & USAGE SECTION

Uses

relieves redness of the eye due to minor eye irritations
as a lubricant to prevent further irritation or to relieve dryness of the eye

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When using this product

pupils may become enlarged temporarily
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
overuse may produce increased redness of the eye
remove contact lens before using

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Instill 1 to 2 drops in the affected eye(s) up to 4 times daily.

OTHER SAFETY INFORMATION

Other information

store at 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
996202	dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	3
996202	dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	3
996202	dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic Solution	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTRAN 70 Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-856-01	TopCare Health Advanced Moisturizing Plus Redness Relief	15 mL in 1 BOTTLE, DROPPER	SOLUTION	15		3
36800-856-01	TopCare Health Advanced Moisturizing Plus Redness Relief	1 in 1 CARTON	SOLUTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-856	TOPCARE HEALTH ADVANCED MOISTURIZING PLUS REDNESS RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231221_9c6193a6-d822-1b27-e053-2995a90ab3cf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

TopCare Health Advanced Moisturizing Plus Redness Relief
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
POVIDONE
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE
POLYETHYLENE GLYCOL 400
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
EDETIC ACID
WATER
SODIUM CHLORIDE
DEXTRAN 70
SODIUM BORATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-856	36800-856-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POVIDONE	FZ989GH94E	ACTIB
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB
POLYETHYLENE GLYCOL 400	B697894SGQ	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
DEXTRAN 70	7SA290YK68	ACTIB
SODIUM BORATE	91MBZ8H3QO	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier ndc (package): 36800-856-01 ndc (product): 36800-856 ndc11 (package): 36800085601 spl id: 0cfa88e0-a3dd-180c-e063-6294a90ae2ac spl set id: 9c6193a6-d822-1b27-e053-2995a90ab3cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.