SOUNDBODY SEASONAL ITCHY AND RED EYE RELIEF- tetrahydrozoline hcl, zinc sulfate liquid

Soundbody Seasonal itchy and Red eye relief by

Drug Labeling and Warnings

Soundbody Seasonal itchy and Red eye relief by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purpose

Redness reliever

Astringent

Use

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

Warnings

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

When using this product

• 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

• 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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• 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

• store at 15° to 25°C (59° to 77°F)

Inactive ingredients

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

package label

Soundbody Eye Drops Seasonal Itchy & Red Eye Relief

INGREDIENTS AND APPEARANCE

SOUNDBODY SEASONAL ITCHY AND RED EYE RELIEF 
tetrahydrozoline hcl, zinc sulfate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0651
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 mg  in 1 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0651-5	1 in 1 CARTON	05/30/2018
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/30/2018

Labeler - Kareway Product, Inc. (121840057)