Soundbody Eye drops Seasonal Itchy & Red Eye Relief

Manufacturer: Kareway Product, Inc.
Effective date: 2022-07-08
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:50:06

Label at a glance#

ProductSoundbody Seasonal itchy and Red eye relief

Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE

Label structure8 sections

Dosage and administration

put 1 to 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age: ask a doctor

Storage and handling

store at 15° to 25°C (59° to 77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Astringent

Use

INDICATIONS & USAGE SECTION

for temporary relief of discomfort and redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

Ask a doctor before use if you have narrow angle glaucoma.

When using this product

OTC - WHEN USING SECTION

pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using
do not use if this solution changes color or become cloudy
do not touch tip of container to any surface to avoid contamination
replace cap after each use

Stop use and ask a doctor if

OTC - STOP USE SECTION

you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts more than 72 hours

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soundbody Eye Drops Seasonal Itchy & Red Eye Relief

carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67510-0651-5	2024-01-30	C162847	48780-1	1030e365-4186-111a-e063-dadaa90a10e2	Soundbody Eye drops Seasonal Itchy & Red Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67510-0651-5	Soundbody Seasonal itchy and Red eye relief	15 mL in 1 BOTTLE	LIQUID	15		3
67510-0651-5	Soundbody Seasonal itchy and Red eye relief	1 in 1 CARTON	LIQUID	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0651	SOUNDBODY SEASONAL ITCHY AND RED EYE RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE) LIQUID [KAREWAY PRODUCT, INC.]	3	Legacy NDC, 2 package rows	20220710_6d87f1d6-1c8e-778a-e053-2991aa0aaa23.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Soundbody Seasonal itchy and Red eye relief
tetrahydrozoline HCl, Zinc sulfate
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
SODIUM CITRATE
SODIUM CHLORIDE
WATER
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE
ZINC SULFATE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-0651	67510-0651-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB
ZINC SULFATE	89DS0H96TB	ACTIM

Source Document#

Source XML · Source PDF

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
e3575286-2db2-d528-e053-2a95a90a19a8			6d87f1d6-1c8e-778a-e053-2991aa0aaa23	2022-07-08	Warnings	Exact identifier spl id: e3575286-2db2-d528-e053-2a95a90a19a8 spl set id: 6d87f1d6-1c8e-778a-e053-2991aa0aaa23

Reported adverse events (FAERS/openFDA)#

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