Soundbody Advanced Relief Eye Drops

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 23:50:07

Label at a glance#

ProductSoundbody Advanced relief

Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE

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 between 15° to 25°C (59°F to 77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%

Purpose

OTC - PURPOSE SECTION

Lubricant

Redness reliever

Use

INDICATIONS & USAGE SECTION

for the relief of redness of the eye due to minor eye irritations
for use as a protectant against further irritation or to relieve dryness of the eye

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 between 15° to 25°C (59°F to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, sodium borate, edetate disodium, benzalkonium chloride, sodium chloride, dilite hydrochloric acid, sterile purified water

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soundbody Advance relief Eye Drops

carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
67510-0652-5	2024-01-30	C162847	48780-1	1030e365-6cb7-111a-e063-dadaa90a10e2	Soundbody Advanced Relief Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67510-0652-5	Soundbody Advanced relief	15 mL in 1 BOTTLE	LIQUID	15		3
67510-0652-5	Soundbody Advanced relief	1 in 1 BOX	LIQUID	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0652	SOUNDBODY ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.]	3	Legacy NDC, 2 package rows	20220710_6d88761a-b765-b938-e053-2a91aa0a7625.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Soundbody Advanced relief
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
BORIC ACID
SODIUM BORATE
EDETATE DISODIUM
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
WATER
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE
DEXTRAN 70
POLYETHYLENE GLYCOL 400
POVIDONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-0652	67510-0652-5

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

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
e3575e0b-76d2-83a7-e053-2a95a90a5409			6d88761a-b765-b938-e053-2a91aa0a7625	2022-07-08	Warnings	Exact identifier spl id: e3575e0b-76d2-83a7-e053-2a95a90a5409 spl set id: 6d88761a-b765-b938-e053-2a91aa0a7625

Reported adverse events (FAERS/openFDA)#

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